3.375 - food and drug administration 20 tablets two 10-count blister cards purdue pharma l.p. purdue...

21
3.375" 1 625" .50” 1.3125” 1.03125” S/N 123456789012 .53125” LOT EXP NO VARN SH LOT/EXP Usual Dosage: Read accompanying prescribing literature. Swallow tablets whole. Do not cut, break, chew, crush, or dissolve. Purdue Pharma L.P. Stamford, CT 06901-3431 xxxxxx-xx NDC 59011-410-10 OxyContin ® (oxycodone hydrochloride extended-release tablets) 100 Tablets R x Only Purdue Pharma L.P. C II 10 mg Dispense in a tight, light-resistant container. Store at 25°C (77°F); excursions permitted between 15°–30°C (59°–86°F). U.S. Patent Nos. 6,488,963; 7,129,248; 7,674,799; 7,674,800; 7,683,072; 7,776,314; 8,114,383; 8,309,060; and 8,337,888. Attention Dispenser: Accompanying Medication Guide must be provided to the patient upon dispensing. Reference ID: 3646951 (b) (4)

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Page 1: 3.375 - Food and Drug Administration 20 Tablets Two 10-count Blister Cards Purdue Pharma L.P. Purdue Pharma L.P., Stamford, CT 06901-3431

3.375"

162

5"

.50” 1.3125” 1.03125”

S/N 123456789012

.53125”

LOT

EXP

NO

VA

RN

SH

LOT/

EX

P

Usu

al D

osag

e: R

ead

acco

mpa

nyin

g pr

escr

ibin

g lit

erat

ure.

Sw

allo

w ta

blet

s w

hole

. Do

not c

ut,

brea

k, c

hew

, cru

sh, o

r dis

solv

e.

Purdue Pharma L.P. Stamford, CT 06901-3431 xxxxxx-xx

NDC 59011-410-10

OxyContin®

(oxycodone hydrochloride extended-release tablets)

100 Tablets Rx OnlyPurdue Pharma L.P.

CII10mg D

ispe

nse

in a

tigh

t, lig

ht-re

sist

ant c

onta

iner

.St

ore

at 2

5°C

(77°

F); e

xcur

sion

s pe

rmitt

ed

betw

een

15°–3

0°C

(59°

–86°

F).

U.S.

Pat

ent N

os. 6

,488

,963

; 7,1

29,2

48; 7

,674

,799

; 7,

674,

800;

7,6

83,0

72; 7

,776

,314

; 8,1

14,3

83;

8,30

9,06

0; a

nd 8

,337

,888

.

Attention Dispenser: Accompanying Medication Guide must be provided to

the patient upon dispensing.

Reference ID: 3646951

(b) (4)

Page 2: 3.375 - Food and Drug Administration 20 Tablets Two 10-count Blister Cards Purdue Pharma L.P. Purdue Pharma L.P., Stamford, CT 06901-3431

3.375"

162

5"

.50” 1.3125” 1.03125”

S/N 123456789012

.53125”

LOT

EXP

NO

VA

RN

SH

LOT/

EX

P

Purdue Pharma L.P. Stamford, CT 06901-3431 xxxxxx-xx

NDC 59011-415-10

OxyContin®

(oxycodone hydrochloride extended-release tablets)

100 Tablets Rx OnlyPurdue Pharma L.P.

CIImg

Attention Dispenser: Accompanying Medication Guide must be provided to

the patient upon dispensing.

Usu

al D

osag

e: R

ead

acco

mpa

nyin

g pr

escr

ibin

g lit

erat

ure.

Sw

allo

w ta

blet

s w

hole

. Do

not c

ut,

brea

k, c

hew

, cru

sh, o

r dis

solv

e.

Dis

pens

e in

a ti

ght,

light

-resi

stan

t con

tain

er.

Stor

e at

25°

C (7

7°F)

; exc

ursi

ons

perm

itted

be

twee

n 15

°–30°

C (5

9°–8

6°F)

.U.

S. P

aten

t Nos

. 6,4

88,9

63; 7

,129

,248

; 7,6

74,7

99;

7,67

4,80

0; 7

,683

,072

; 7,7

76,3

14; 8

,114

,383

; 8,

309,

060;

and

8,3

37,8

88.

Reference ID: 3646951

(b) (4)

Page 3: 3.375 - Food and Drug Administration 20 Tablets Two 10-count Blister Cards Purdue Pharma L.P. Purdue Pharma L.P., Stamford, CT 06901-3431

3.375"

162

5"

.50” 1.3125” 1.03125”

S/N 123456789012

.53125”

LOT

EXP

NO

VA

RN

SH

LOT/

EX

P

Purdue Pharma L.P. Stamford, CT 06901-3431 xxxxxx-xx

NDC 59011-420-10

OxyContin®

(oxycodone hydrochloride extended-release tablets)

100 Tablets Rx OnlyPurdue Pharma L.P.

CII20mg

Attention Dispenser: Accompanying Medication Guide must be provided to

the patient upon dispensing.

Usu

al D

osag

e: R

ead

acco

mpa

nyin

g pr

escr

ibin

g lit

erat

ure.

Sw

allo

w ta

blet

s w

hole

. Do

not c

ut,

brea

k, c

hew

, cru

sh, o

r dis

solv

e.

Dis

pens

e in

a ti

ght,

light

-resi

stan

t con

tain

er.

Stor

e at

25°

C (7

7°F)

; exc

ursi

ons

perm

itted

be

twee

n 15

°–30°

C (5

9°–8

6°F)

.U.

S. P

aten

t Nos

. 6,4

88,9

63; 7

,129

,248

; 7,6

74,7

99;

7,67

4,80

0; 7

,683

,072

; 7,7

76,3

14; 8

,114

,383

; 8,

309,

060;

and

8,3

37,8

88.

Reference ID: 3646951

(b) (4)

Page 4: 3.375 - Food and Drug Administration 20 Tablets Two 10-count Blister Cards Purdue Pharma L.P. Purdue Pharma L.P., Stamford, CT 06901-3431

3.375"

162

5"

.50” 1.3125” 1.03125”

S/N 123456789012

.53125”

LOT

EXP

NO

VA

RN

SH

LOT/

EX

P

Purdue Pharma L.P. Stamford, CT 06901-3431 xxxxxx-xx

NDC 59011-430-10

OxyContin®

(oxycodone hydrochloride extended-release tablets)

100 Tablets Rx OnlyPurdue Pharma L.P.

CIImg

Attention Dispenser: Accompanying Medication Guide must be provided to

the patient upon dispensing.

Usu

al D

osag

e: R

ead

acco

mpa

nyin

g pr

escr

ibin

g lit

erat

ure.

Sw

allo

w ta

blet

s w

hole

. Do

not c

ut,

brea

k, c

hew

, cru

sh, o

r dis

solv

e.

Dis

pens

e in

a ti

ght,

light

-resi

stan

t con

tain

er.

Stor

e at

25°

C (7

7°F)

; exc

ursi

ons

perm

itted

be

twee

n 15

°–30°

C (5

9°–8

6°F)

.U.

S. P

aten

t Nos

. 6,4

88,9

63; 7

,129

,248

; 7,6

74,7

99;

7,67

4,80

0; 7

,683

,072

; 7,7

76,3

14; 8

,114

,383

; 8,

309,

060;

and

8,3

37,8

88.

Reference ID: 3646951

(b) (4)

Page 5: 3.375 - Food and Drug Administration 20 Tablets Two 10-count Blister Cards Purdue Pharma L.P. Purdue Pharma L.P., Stamford, CT 06901-3431

3.375"

162

5"

.50” 1.3125” 1.03125”

S/N 123456789012

.53125”

LOT

EXP

NO

VA

RN

SH

LOT/

EX

P

Purdue Pharma L.P. Stamford, CT 06901-3431 xxxxxx-xx

NDC 59011-440-10

OxyContin®

(oxycodone hydrochloride extended-release tablets)

100 Tablets Rx OnlyPurdue Pharma L.P.

CIImg

Attention Dispenser: Accompanying Medication Guide must be provided to

the patient upon dispensing.

Usu

al D

osag

e: R

ead

acco

mpa

nyin

g pr

escr

ibin

g lit

erat

ure.

Sw

allo

w ta

blet

s w

hole

. Do

not c

ut,

brea

k, c

hew

, cru

sh, o

r dis

solv

e.

Dis

pens

e in

a ti

ght,

light

-resi

stan

t con

tain

er.

Stor

e at

25°

C (7

7°F)

; exc

ursi

ons

perm

itted

be

twee

n 15

°–30°

C (5

9°–8

6°F)

.U.

S. P

aten

t Nos

. 6,4

88,9

63; 7

,129

,248

; 7,6

74,7

99;

7,67

4,80

0; 7

,683

,072

; 7,7

76,3

14; 8

,114

,383

; 8,

309,

060;

and

8,3

37,8

88.

Reference ID: 3646951

(b) (4)

Page 6: 3.375 - Food and Drug Administration 20 Tablets Two 10-count Blister Cards Purdue Pharma L.P. Purdue Pharma L.P., Stamford, CT 06901-3431

3.375"

162

5"

.50” 1.3125” 1.03125”

S/N 123456789012

.53125”

LOT

EXP

NO

VA

RN

SH

LOT/

EX

P

Purdue Pharma L.P. Stamford, CT 06901-3431 xxxxxx-xx

CIINDC 59011-460-10

OxyContin®

(oxycodone hydrochloride extended-release tablets)

Attention Dispenser: Accompanying Medication Guide must be provided to

the patient upon dispensing.

for u

se in

opio

id-to

leran

t

pat e

ts o

nly

100 Tablets Rx Only

mg 80Usu

al D

osag

e: R

ead

acco

mpa

nyin

g pr

escr

ibin

g lit

erat

ure.

Sw

allo

w ta

blet

s w

hole

. Do

not c

ut,

brea

k, c

hew

, cru

sh, o

r dis

solv

e.

Dis

pens

e in

a ti

ght,

light

-resi

stan

t con

tain

er.

Stor

e at

25°

C (7

7°F)

; exc

ursi

ons

perm

itted

be

twee

n 15

°–30°

C (5

9°–8

6°F)

.U.

S. P

aten

t Nos

. 6,4

88,9

63; 7

,129

,248

; 7,6

74,7

99;

7,67

4,80

0; 7

,683

,072

; 7,7

76,3

14; 8

,114

,383

; 8,

309,

060;

and

8,3

37,8

88.

Reference ID: 3646951

(b) (4)

Page 7: 3.375 - Food and Drug Administration 20 Tablets Two 10-count Blister Cards Purdue Pharma L.P. Purdue Pharma L.P., Stamford, CT 06901-3431

3.375"

162

5"

.50” 1.3125” 1.03125”

S/N 123456789012

.53125”

LOT

EXP

NO

VA

RN

SH

LOT/

EX

PCII

for u

se in

opio

id-to

leran

t

patie

nts o

nly

80mg

Attention Dispenser: Accompanying Medication Guide must be provided to

the patient upon dispensing.

NDC 59011-480-10

OxyContin®

(oxycodone hydrochloride extended-release tablets)

100 Tablets Rx Only

Purdue Pharma L.P. Stamford, CT 06901-3431 xxxxxx-xx

Usu

al D

osag

e: R

ead

acco

mpa

nyin

g pr

escr

ibin

g lit

erat

ure.

Sw

allo

w ta

blet

s w

hole

. Do

not c

ut,

brea

k, c

hew

, cru

sh, o

r dis

solv

e.

Dis

pens

e in

a ti

ght,

light

-resi

stan

t con

tain

er.

Stor

e at

25°

C (7

7°F)

; exc

ursi

ons

perm

itted

be

twee

n 15

°–30°

C (5

9°–8

6°F)

.U.

S. P

aten

t Nos

. 6,4

88,9

63; 7

,129

,248

; 7,6

74,7

99;

7,67

4,80

0; 7

,683

,072

; 7,7

76,3

14; 8

,114

,383

; 8,

309,

060;

and

8,3

37,8

88.

Reference ID: 3646951

(b) (4)

Page 8: 3.375 - Food and Drug Administration 20 Tablets Two 10-count Blister Cards Purdue Pharma L.P. Purdue Pharma L.P., Stamford, CT 06901-3431

OxyContin®

CII(oxycodone hydrochloride extended-release tablets)

Rx OnlyStore at 25°C (77°F); excursions permitted between 15°–30°C (59°–86°F).

FOR HOSPITAL USE

NDC 59011-410-20 20 Tablets Two 10-count Blister Cards

Purdue Pharma L.P.

Purdue Pharma L.P., Stamford, CT 06901-3431U.S. Patent Nos. 6,488,963; 7,129,248; 7,674,799; 7,674,800; 7,683,072; 7,776,314; 8,114,383; 8,309,060; and 8,337,888. ©2014, Purdue Pharma L.P. xxxxxx-xx

NDC 59011-410-20 20 Tablets Two 10-count Blister Cards

OxyContin® CII(oxycodone hydrochloride extended-release tablets)

Rx Only

Store at 25°C (77°F); excursions permitted between 15°–30°C (59°–86°F).FOR HOSPITAL USEUsual Dosage: Read accompanying prescribing literature. OxyContin Tablets must be swallowed whole and must not be cut, broken, chewed, crushed, or dissolved. Caution: Keep out of reach of children. This package is not child resistant.

0mg

OxyContin® (oxycodone hydrochloride extended-release tablets)0mg 20mg m mg mg 80mgmg

O

xyC

ontin

®

(oxy

codo

ne h

ydro

chlo

ride

exte

nded

-rele

ase

tabl

ets)

0mg

20m

g

10mg

Attention Dispenser: The enclosed Medication Guide must be provided to the patient

upon dispensing.

FPO

Bar

Cod

eLo

t/Exp

Are

aN

o Va

rnis

h

53 / 32

33 / 8

1.06

3

2

FPO

Bar

Cod

e

No

Varn

ish

Glu

e Fl

ap

No

Varn

ish

Glu

e Fl

ap

Lot/E

xp B

ox p

rints

dar

k co

lor w

ith n

o va

rnis

h

PD

DIE

-180

HU

D C

arto

n

Reference ID: 3646951

(b) (4)

Page 9: 3.375 - Food and Drug Administration 20 Tablets Two 10-count Blister Cards Purdue Pharma L.P. Purdue Pharma L.P., Stamford, CT 06901-3431

OxyContin®

CII(oxycodone hydrochloride extended-release tablets)

Rx OnlyStore at 25°C (77°F); excursions permitted between 15°–30°C (59°–86°F).

FOR HOSPITAL USE

NDC 59011-415-20 20 Tablets Two 10-count Blister Cards

Purdue Pharma L.P.

Purdue Pharma L.P., Stamford, CT 06901-3431U.S. Patent Nos. 6,488,963; 7,129,248; 7,674,799; 7,674,800; 7,683,072; 7,776,314; 8,114,383; 8,309,060; and 8,337,888. ©2014, Purdue Pharma L.P. xxxxxx-xx

NDC 59011-415-20 20 Tablets Two 10-count Blister Cards

OxyContin® CII(oxycodone hydrochloride extended-release tablets)

Rx Only

Store at 25°C (77°F); excursions permitted between 15°–30°C (59°–86°F).FOR HOSPITAL USEUsual Dosage: Read accompanying prescribing literature. OxyContin Tablets must be swallowed whole and must not be cut, broken, chewed, crushed, or dissolved. Caution: Keep out of reach of children. This package is not child resistant.

mg

OxyContin® (oxycodone hydrochloride extended-release tablets)20mg g mg mg 80mgmg

O

xyC

ontin

®

(oxy

codo

ne h

ydro

chlo

ride

exte

nded

-rele

ase

tabl

ets)

20m

gm

g

mg

Attention Dispenser: The enclosed Medication Guide must be provided to the patient

upon dispensing.

FPO

Bar

Cod

eLo

t/Exp

Are

aN

o Va

rnis

h

53 / 32

33 / 8

1.06

3

2

FPO

Bar

Cod

e

No

Varn

ish

Glu

e Fl

ap

No

Varn

ish

Glu

e Fl

ap

Lot/E

xp B

ox p

rints

dar

k co

lor w

ith n

o va

rnis

h

PD

DIE

-180

HU

D C

arto

n

Reference ID: 3646951

(b) (4)

Page 10: 3.375 - Food and Drug Administration 20 Tablets Two 10-count Blister Cards Purdue Pharma L.P. Purdue Pharma L.P., Stamford, CT 06901-3431

OxyContin®

CII(oxycodone hydrochloride extended-release tablets)

Rx OnlyStore at 25°C (77°F); excursions permitted between 15°–30°C (59°–86°F).

FOR HOSPITAL USE

NDC 59011-420-20 20 Tablets Two 10-count Blister Cards

Purdue Pharma L.P.

Purdue Pharma L.P., Stamford, CT 06901-3431U.S. Patent Nos. 6,488,963; 7,129,248; 7,674,799; 7,674,800; 7,683,072; 7,776,314; 8,114,383; 8,309,060; and 8,337,888. ©2014, Purdue Pharma L.P. xxxxxx-xx

NDC 59011-420-20 20 Tablets Two 10-count Blister Cards

OxyContin® CII(oxycodone hydrochloride extended-release tablets)

Rx Only

Store at 25°C (77°F); excursions permitted between 15°–30°C (59°–86°F).FOR HOSPITAL USEUsual Dosage: Read accompanying prescribing literature. OxyContin Tablets must be swallowed whole and must not be cut, broken, chewed, crushed, or dissolved. Caution: Keep out of reach of children. This package is not child resistant.

20mg

OxyContin® (oxycodone hydrochloride extended-release tablets)20mg mg mg m 80mg

O

xyC

ontin

®

(oxy

codo

ne h

ydro

chlo

ride

exte

nded

-rele

ase

tabl

ets)

20m

gm

gm

m20mg

Attention Dispenser: The enclosed Medication Guide must be provided to the patient

upon dispensing.

FPO

Bar

Cod

eLo

t/Exp

Are

aN

o Va

rnis

h

53 / 32

33 / 8

1.06

3

2

FPO

Bar

Cod

e

No

Varn

ish

Glu

e Fl

ap

No

Varn

ish

Glu

e Fl

ap

Lot/E

xp B

ox p

rints

dar

k co

lor w

ith n

o va

rnis

h

PD

DIE

-180

HU

D C

arto

n

Reference ID: 3646951

(b) (4)

Page 11: 3.375 - Food and Drug Administration 20 Tablets Two 10-count Blister Cards Purdue Pharma L.P. Purdue Pharma L.P., Stamford, CT 06901-3431

OxyContin®

CII(oxycodone hydrochloride extended-release tablets)

Rx OnlyStore at 25°C (77°F); excursions permitted between 15°–30°C (59°–86°F).

FOR HOSPITAL USE

NDC 59011-430-20 20 Tablets Two 10-count Blister Cards

Purdue Pharma L.P.

Purdue Pharma L.P., Stamford, CT 06901-3431U.S. Patent Nos. 6,488,963; 7,129,248; 7,674,799; 7,674,800; 7,683,072; 7,776,314; 8,114,383; 8,309,060; and 8,337,888. ©2014, Purdue Pharma L.P. xxxxxx-xx

NDC 59011-430-20 20 Tablets Two 10-count Blister Cards

OxyContin® CII(oxycodone hydrochloride extended-release tablets)

Rx Only

Store at 25°C (77°F); excursions permitted between 15°–30°C (59°–86°F).FOR HOSPITAL USEUsual Dosage: Read accompanying prescribing literature. OxyContin Tablets must be swallowed whole and must not be cut, broken, chewed, crushed, or dissolved. Caution: Keep out of reach of children. This package is not child resistant.

mg

OxyContin® (oxycodone hydrochloride extended-release tablets)mg mg g 80mg

O

xyC

ontin

®

(oxy

codo

ne h

ydro

chlo

ride

exte

nded

-rele

ase

tabl

ets)

mg

mg

mg

Attention Dispenser: The enclosed Medication Guide must be provided to the patient

upon dispensing.

FPO

Bar

Cod

eLo

t/Exp

Are

aN

o Va

rnis

h

53 / 32

33 / 8

1.06

3

2

FPO

Bar

Cod

e

No

Varn

ish

Glu

e Fl

ap

No

Varn

ish

Glu

e Fl

ap

Lot/E

xp B

ox p

rints

dar

k co

lor w

ith n

o va

rnis

h

PD

DIE

-180

HU

D C

arto

n

Reference ID: 3646951

(b) (4)

Page 12: 3.375 - Food and Drug Administration 20 Tablets Two 10-count Blister Cards Purdue Pharma L.P. Purdue Pharma L.P., Stamford, CT 06901-3431

OxyContin®

CII(oxycodone hydrochloride extended-release tablets)

Rx OnlyStore at 25°C (77°F); excursions permitted between 15°–30°C (59°–86°F).

FOR HOSPITAL USE

NDC 59011-440-20 20 Tablets Two 10-count Blister Cards

Purdue Pharma L.P.

Purdue Pharma L.P., Stamford, CT 06901-3431U.S. Patent Nos. 6,488,963; 7,129,248; 7,674,799; 7,674,800; 7,683,072; 7,776,314; 8,114,383; 8,309,060; and 8,337,888. ©2014, Purdue Pharma L.P. xxxxxx-xx

NDC 59011-440-20 20 Tablets Two 10-count Blister Cards

OxyContin® CII(oxycodone hydrochloride extended-release tablets)

Rx Only

Store at 25°C (77°F); excursions permitted between 15°–30°C (59°–86°F).FOR HOSPITAL USEUsual Dosage: Read accompanying prescribing literature. OxyContin Tablets must be swallowed whole and must not be cut, broken, chewed, crushed, or dissolved. Caution: Keep out of reach of children. This package is not child resistant.

mg

OxyContin® (oxycodone hydrochloride extended-release tablets)mg mg 0mg

O

xyC

ontin

®

(oxy

codo

ne h

ydro

chlo

ride

exte

nded

-rele

ase

tabl

ets)

mg

mg

0mg

Attention Dispenser: The enclosed Medication Guide must be provided to the patient

upon dispensing.

FPO

Bar

Cod

eLo

t/Exp

Are

aN

o Va

rnis

h

53 / 32

33 / 8

1.06

3

2

FPO

Bar

Cod

e

No

Varn

ish

Glu

e Fl

ap

No

Varn

ish

Glu

e Fl

ap

Lot/E

xp B

ox p

rints

dar

k co

lor w

ith n

o va

rnis

h

PD

DIE

-180

HU

D C

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Reference ID: 3646951

(b) (4)

Page 13: 3.375 - Food and Drug Administration 20 Tablets Two 10-count Blister Cards Purdue Pharma L.P. Purdue Pharma L.P., Stamford, CT 06901-3431

FPO

Bar

Cod

e

53 / 32

33 / 8

1.06

3

2

FPO

Bar

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Purdue Pharma L.P., Stamford, CT 06901-3431U.S. Patent Nos. 6,488,963; 7,129,248; 7,674,799; 7,674,800; 7,683,072; 7,776,314; 8,114,383; 8,309,060; and 8,337,888. ©2014, Purdue Pharma L.P. xxxxxx-xx

OxyContin®

CII(oxycodone hydrochloride extended-release tablets)

Rx OnlyStore at 25°C (77°F); excursions permitted between 15°–30°C (59°–86°F).

FOR HOSPITAL USE

NDC 59011-460-20 20 Tablets Two 10-count Blister Cards

Purdue Pharma L.P.

mg

for use in

opioid-tolerant

patients only

Attention Dispenser: The enclosed Medication Guide must be provided to the patient

upon dispensing.

NDC 59011-460-20 20 Tablets Two 10-count Blister Cards

OxyContin® CII(oxycodone hydrochloride extended-release tablets)

Rx Only Store at 25°C (77°F); excursions permitted between 15°–30°C (59°–86°F).FOR HOSPITAL USEUsual Dosage: Read accompanying prescribing literature. OxyContin Tablets must be swallowed whole and must not be cut, broken, chewed, crushed, or dissolved. Caution: Keep out of reach of children. This package is not child resistant.

mg

for u

se in

opio

id-to

leran

t

patie

nts

only

OxyContin® (oxycodone hydrochloride extended-release tablets)0 mg 80mg

Oxy

Con

tin®

(oxy

codo

ne h

ydro

chlo

ride

exte

nded

-rele

ase

tabl

ets)

mg

80m

g

Reference ID: 3646951

(b) (4)

Page 14: 3.375 - Food and Drug Administration 20 Tablets Two 10-count Blister Cards Purdue Pharma L.P. Purdue Pharma L.P., Stamford, CT 06901-3431

FPO

Bar

Cod

e

53 / 32

33 / 8

1.06

3

2

FPO

Bar

Cod

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No

Varn

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Glu

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ap

No

Varn

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OxyContin®

CII(oxycodone hydrochloride extended-release tablets)

Rx OnlyStore at 25°C (77°F); excursions permitted between 15°–30°C (59°–86°F).

FOR HOSPITAL USE

NDC 59011-480-20 20 Tablets Two 10-count Blister Cards

Purdue Pharma L.P.

mg80mg

for use in

opioid-tolerant

patients only

Attention Dispenser: The enclosed Medication Guide must be provided to the patient

upon dispensing.

NDC 59011-480-20 20 Tablets Two 10-count Blister Cards

OxyContin® CII(oxycodone hydrochloride extended-release tablets)

Rx Only Store at 25°C (77°F); excursions permitted between 15°–30°C (59°–86°F).FOR HOSPITAL USEUsual Dosage: Read accompanying prescribing literature. OxyContin Tablets must be swallowed whole and must not be cut, broken, chewed, crushed, or dissolved. Caution: Keep out of reach of children. This package is not child resistant.

80mg

for u

se in

opio

id-to

leran

t

patie

nts

only

OxyContin® (oxycodone hydrochloride extended-release tablets)80mgm

Oxy

Con

tin®

(oxy

codo

ne h

ydro

chlo

ride

exte

nded

-rele

ase

tabl

ets)

1m

g80

mg

Purdue Pharma L.P., Stamford, CT 06901-3431U.S. Patent Nos. 6,488,963; 7,129,248; 7,674,799; 7,674,800; 7,683,072; 7,776,314; 8,114,383; 8,309,060; and 8,337,888. ©2014, Purdue Pharma L.P. xxxxxx-xx

Reference ID: 3646951

(b) (4)

Page 15: 3.375 - Food and Drug Administration 20 Tablets Two 10-count Blister Cards Purdue Pharma L.P. Purdue Pharma L.P., Stamford, CT 06901-3431

120mm

80mm

24mm

40mm

Shaded Area = No Print Area

1 2

7

9

3 4

5 6

8

10

(01

)20

35

90

11

41

02

04

OxyContin®

(oxycodone hydrochloride extended-release tablets)

10 mg Purdue Pharma L.P.

LOT# XXXXXX EXP MM/YY

CII

xxxx

xx-x

x

(01

)20

35

90

11

41

02

04 LOT# XXXXXX EXP MM/YY

OxyContin®

(oxycodone hydrochloride extended-release tablets)

10 mg Purdue Pharma L.P.

CII

(01

)20

35

90

11

41

02

04 LOT# XXXXXX EXP MM/YY

OxyContin®

(oxycodone hydrochloride extended-release tablets)

10 mg Purdue Pharma L.P.

CII

(01

)20

35

90

11

41

02

04 LOT# XXXXXX EXP MM/YY

OxyContin®

(oxycodone hydrochloride extended-release tablets)

10 mg Purdue Pharma L.P.

CII

(01

)20

35

90

11

41

02

04 LOT# XXXXXX EXP MM/YY

OxyContin®

(oxycodone hydrochloride extended-release tablets)

10 mg Purdue Pharma L.P.

CII

(01

)20

35

90

11

41

02

04 LOT# XXXXXX EXP MM/YY

OxyContin®

(oxycodone hydrochloride extended-release tablets)

10 mg Purdue Pharma L.P.

CII

(01

)20

35

90

11

41

02

04 LOT# XXXXXX EXP MM/YY

OxyContin®

(oxycodone hydrochloride extended-release tablets)

10 mg Purdue Pharma L.P.

CII

(01

)20

35

90

11

41

02

04 LOT# XXXXXX EXP MM/YY

OxyContin®

(oxycodone hydrochloride extended-release tablets)

10 mg Purdue Pharma L.P.

CII(0

1)2

03

59

01

14

10

20

4 LOT# XXXXXX EXP MM/YY

OxyContin®

(oxycodone hydrochloride extended-release tablets)

10 mg Purdue Pharma L.P.

CII

(01

)20

35

90

11

41

02

04 LOT# XXXXXX EXP MM/YY

OxyContin®

(oxycodone hydrochloride extended-release tablets)

10 mg Purdue Pharma L.P.

CII

Reference ID: 3646951

(b) (4)

Page 16: 3.375 - Food and Drug Administration 20 Tablets Two 10-count Blister Cards Purdue Pharma L.P. Purdue Pharma L.P., Stamford, CT 06901-3431

120mm

80mm

24mm

40mm

Shaded Area = No Print Area

1 2

7

9

3 4

5 6

8

10

(01

)20

35

90

11

41

52

09 LOT# XXXXXX EXP MM/YY

OxyContin®

(oxycodone hydrochloride extended-release tablets)

15 mg Purdue Pharma L.P.

CII

xxxx

xx-x

x

(01

)20

35

90

11

41

52

09 LOT# XXXXXX EXP MM/YY

OxyContin®

(oxycodone hydrochloride extended-release tablets)

15 mg Purdue Pharma L.P.

CII

(01

)20

35

90

11

41

52

09 LOT# XXXXXX EXP MM/YY

OxyContin®

(oxycodone hydrochloride extended-release tablets)

15 mg Purdue Pharma L.P.

CII

(01

)20

35

90

11

41

52

09 LOT# XXXXXX EXP MM/YY

OxyContin®

(oxycodone hydrochloride extended-release tablets)

15 mg Purdue Pharma L.P.

CII

(01

)20

35

90

11

41

52

09 LOT# XXXXXX EXP MM/YY

OxyContin®

(oxycodone hydrochloride extended-release tablets)

15 mg Purdue Pharma L.P.

CII

(01

)20

35

90

11

41

52

09 LOT# XXXXXX EXP MM/YY

OxyContin®

(oxycodone hydrochloride extended-release tablets)

15 mg Purdue Pharma L.P.

CII

(01

)20

35

90

11

41

52

09 LOT# XXXXXX EXP MM/YY

OxyContin®

(oxycodone hydrochloride extended-release tablets)

15 mg Purdue Pharma L.P.

CII

(01

)20

35

90

11

41

52

09 LOT# XXXXXX EXP MM/YY

OxyContin®

(oxycodone hydrochloride extended-release tablets)

15 mg Purdue Pharma L.P.

CII(0

1)2

03

59

01

14

15

20

9 LOT# XXXXXX EXP MM/YY

OxyContin®

(oxycodone hydrochloride extended-release tablets)

15 mg Purdue Pharma L.P.

CII

(01

)20

35

90

11

41

52

09 LOT# XXXXXX EXP MM/YY

OxyContin®

(oxycodone hydrochloride extended-release tablets)

15 mg Purdue Pharma L.P.

CII

Reference ID: 3646951

(b) (4)

Page 17: 3.375 - Food and Drug Administration 20 Tablets Two 10-count Blister Cards Purdue Pharma L.P. Purdue Pharma L.P., Stamford, CT 06901-3431

120mm

80mm

24mm

40mm

Shaded Area = No Print Area

1 2

7

9

3 4

5 6

8

10

(01

)20

35

90

11

42

02

03 LOT# XXXXXX EXP MM/YY

OxyContin®

(oxycodone hydrochloride extended-release tablets)

20 mg Purdue Pharma L.P.

CII

xxxx

xx-x

x

(01

)20

35

90

11

42

02

03 LOT# XXXXXX EXP MM/YY

OxyContin®

(oxycodone hydrochloride extended-release tablets)

20 mg Purdue Pharma L.P.

CII

(01

)20

35

90

11

42

02

03 LOT# XXXXXX EXP MM/YY

OxyContin®

(oxycodone hydrochloride extended-release tablets)

20 mg Purdue Pharma L.P.

CII

(01

)20

35

90

11

42

02

03 LOT# XXXXXX EXP MM/YY

OxyContin®

(oxycodone hydrochloride extended-release tablets)

20 mg Purdue Pharma L.P.

CII

(01

)20

35

90

11

42

02

03 LOT# XXXXXX EXP MM/YY

OxyContin®

(oxycodone hydrochloride extended-release tablets)

20 mg Purdue Pharma L.P.

CII

(01

)20

35

90

11

42

02

03 LOT# XXXXXX EXP MM/YY

OxyContin®

(oxycodone hydrochloride extended-release tablets)

20 mg Purdue Pharma L.P.

CII

(01

)20

35

90

11

42

02

03 LOT# XXXXXX EXP MM/YY

OxyContin®

(oxycodone hydrochloride extended-release tablets)

20 mg Purdue Pharma L.P.

CII

(01

)20

35

90

11

42

02

03 LOT# XXXXXX EXP MM/YY

OxyContin®

(oxycodone hydrochloride extended-release tablets)

20 mg Purdue Pharma L.P.

CII(0

1)2

03

59

01

14

20

20

3 LOT# XXXXXX EXP MM/YY

OxyContin®

(oxycodone hydrochloride extended-release tablets)

20 mg Purdue Pharma L.P.

CII

(01

)20

35

90

11

42

02

03 LOT# XXXXXX EXP MM/YY

OxyContin®

(oxycodone hydrochloride extended-release tablets)

20 mg Purdue Pharma L.P.

CII

Reference ID: 3646951

(b) (4)

Page 18: 3.375 - Food and Drug Administration 20 Tablets Two 10-count Blister Cards Purdue Pharma L.P. Purdue Pharma L.P., Stamford, CT 06901-3431

120mm

80mm

24mm

40mm

Shaded Area = No Print Area

2

7

9

3 4

5 6

8

10

1(01

)20

35

90

11

43

02

02 LOT# XXXXXX EXP MM/YY

OxyContin®

(oxycodone hydrochloride extended-release tablets)

30 mg Purdue Pharma L.P.

CII

xxxx

xx-x

x

42

OxyContin®

(oxycodone hydrochloride extended-release tablets)

30 mg Purdue Pharma L.P.

CII

(01

)20

35

90

11

43

02

02 LOT# XXXXXX EXP MM/YY

CII

(01

)20

35

90

11

43

02

02 LOT# XXXXXX EXP MM/YY

OxyContin®

(oxycodone hydrochloride extended-release tablets)

30 mg Purdue Pharma L.P.

CII

(01

)20

35

90

11

43

02

02 LOT# XXXXXX EXP MM/YY

OxyContin®

(oxycodone hydrochloride extended-release tablets)

30 mg Purdue Pharma L.P.

CII

(01

)20

35

90

11

43

02

02 LOT# XXXXXX EXP MM/YY

OxyContin®

(oxycodone hydrochloride extended-release tablets)

30 mg Purdue Pharma L.P.

CII

(01

)20

35

90

11

43

02

02 LOT# XXXXXX EXP MM/YY

OxyContin®

(oxycodone hydrochloride extended-release tablets)

30 mg Purdue Pharma L.P.

CII

(01

)20

35

90

11

43

02

02 LOT# XXXXXX EXP MM/YY

OxyContin®

(oxycodone hydrochloride extended-release tablets)

30 mg Purdue Pharma L.P.

CII

(01

)20

35

90

11

43

02

02 LOT# XXXXXX EXP MM/YY

OxyContin®

(oxycodone hydrochloride extended-release tablets)

30 mg Purdue Pharma L.P.

CII(0

1)2

03

59

01

14

30

20

2 LOT# XXXXXX EXP MM/YY

OxyContin®

(oxycodone hydrochloride extended-release tablets)

30 mg Purdue Pharma L.P.

CII

(01

)20

35

90

11

43

02

02 LOT# XXXXXX EXP MM/YY

OxyContin®

(oxycodone hydrochloride extended-release tablets)

30 mg Purdue Pharma L.P.

CII

Reference ID: 3646951

(b) (4)

Page 19: 3.375 - Food and Drug Administration 20 Tablets Two 10-count Blister Cards Purdue Pharma L.P. Purdue Pharma L.P., Stamford, CT 06901-3431

120mm

80mm

24mm

40mm

Shaded Area = No Print Area

1 2

7

9

3 4

5 6

8

10

(01

)20

35

90

11

44

02

01 LOT# XXXXXX EXP MM/YY

OxyContin®

(oxycodone hydrochloride extended-release tablets)

40 mg Purdue Pharma L.P.

CII

xxxx

xx-x

x

(01

)20

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90

11

44

02

01 LOT# XXXXXX EXP MM/YY

OxyContin®

(oxycodone hydrochloride extended-release tablets)

40 mg Purdue Pharma L.P.

CII

(01

)20

35

90

11

44

02

01 LOT# XXXXXX EXP MM/YY

OxyContin®

(oxycodone hydrochloride extended-release tablets)

40 mg Purdue Pharma L.P.

CII

(01

)20

35

90

11

44

02

01 LOT# XXXXXX EXP MM/YY

OxyContin®

(oxycodone hydrochloride extended-release tablets)

40 mg Purdue Pharma L.P.

CII

(01

)20

35

90

11

44

02

01 LOT# XXXXXX EXP MM/YY

OxyContin®

(oxycodone hydrochloride extended-release tablets)

40 mg Purdue Pharma L.P.

CII

(01

)20

35

90

11

44

02

01 LOT# XXXXXX EXP MM/YY

OxyContin®

(oxycodone hydrochloride extended-release tablets)

40 mg Purdue Pharma L.P.

CII

(01

)20

35

90

11

44

02

01 LOT# XXXXXX EXP MM/YY

OxyContin®

(oxycodone hydrochloride extended-release tablets)

40 mg Purdue Pharma L.P.

CII

(01

)20

35

90

11

44

02

01 LOT# XXXXXX EXP MM/YY

OxyContin®

(oxycodone hydrochloride extended-release tablets)

40 mg Purdue Pharma L.P.

CII(0

1)2

03

59

01

14

40

20

1 LOT# XXXXXX EXP MM/YY

OxyContin®

(oxycodone hydrochloride extended-release tablets)

40 mg Purdue Pharma L.P.

CII

(01

)20

35

90

11

44

02

01 LOT# XXXXXX EXP MM/YY

OxyContin®

(oxycodone hydrochloride extended-release tablets)

40 mg Purdue Pharma L.P.

CII

Reference ID: 3646951

(b) (4)

Page 20: 3.375 - Food and Drug Administration 20 Tablets Two 10-count Blister Cards Purdue Pharma L.P. Purdue Pharma L.P., Stamford, CT 06901-3431

120mm

80mm

24mm

40mm

Shaded Area = No Print Area

1 2

7

9

3 4

5 6

8

10

(01

)20

35

90

11

46

02

09

OxyContin®

(oxycodone hydrochloride extended-release tablets)

60 mg Purdue Pharma L.P.

LOT# XXXXXX EXP MM/YY

CII

xxxx

xx-x

x

(01

)20

35

90

11

46

02

09

OxyContin®

(oxycodone hydrochloride extended-release tablets)

60 mg Purdue Pharma L.P.

LOT# XXXXXX EXP MM/YY

CII

(01

)20

35

90

11

46

02

09

OxyContin®

(oxycodone hydrochloride extended-release tablets)

60 mg Purdue Pharma L.P.

LOT# XXXXXX EXP MM/YY

CII

(01

)20

35

90

11

46

02

09

OxyContin®

(oxycodone hydrochloride extended-release tablets)

60 mg Purdue Pharma L.P.

LOT# XXXXXX EXP MM/YY

CII

(01

)20

35

90

11

46

02

09

OxyContin®

(oxycodone hydrochloride extended-release tablets)

60 mg Purdue Pharma L.P.

LOT# XXXXXX EXP MM/YY

CII

(01

)20

35

90

11

46

02

09

OxyContin®

(oxycodone hydrochloride extended-release tablets)

60 mg Purdue Pharma L.P.

LOT# XXXXXX EXP MM/YY

CII

(01

)20

35

90

11

46

02

09

OxyContin®

(oxycodone hydrochloride extended-release tablets)

6 mg Purdue Pharma L.P.

LOT# XXXXXX EXP MM/YY

CII

(01

)20

35

90

11

46

02

09

OxyContin®

(oxycodone hydrochloride extended-release tablets)

6 mg Purdue Pharma L.P.

LOT# XXXXXX EXP MM/YY

CII(0

1)2

03

59

01

14

60

20

9

OxyContin®

(oxycodone hydrochloride extended-release tablets)

6 mg Purdue Pharma L.P.

LOT# XXXXXX EXP MM/YY

CII

(01

)20

35

90

11

46

02

09

OxyContin®

(oxycodone hydrochloride extended-release tablets)

60 mg Purdue Pharma L.P.

LOT# XXXXXX EXP MM/YY

CII

Reference ID: 3646951

(b) (4)

Page 21: 3.375 - Food and Drug Administration 20 Tablets Two 10-count Blister Cards Purdue Pharma L.P. Purdue Pharma L.P., Stamford, CT 06901-3431

120mm

80mm

24mm

40mm

Shaded Area = No Print Area

1 2

7

9

3 4

5 6

8

10

(01

)20

35

90

11

48

02

07 LOT# XXXXXX EXP MM/YY

OxyContin®

(oxycodone hydrochloride extended-release tablets)

80 mg Purdue Pharma L.P.

CII

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(01

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35

90

11

48

02

07 LOT# XXXXXX EXP MM/YY

OxyContin®

(oxycodone hydrochloride extended-release tablets)

80 mg Purdue Pharma L.P.

CII

(01

)20

35

90

11

48

02

07 LOT# XXXXXX EXP MM/YY

OxyContin®

(oxycodone hydrochloride extended-release tablets)

80 mg Purdue Pharma L.P.

CII

(01

)20

35

90

11

48

02

07 LOT# XXXXXX EXP MM/YY

OxyContin®

(oxycodone hydrochloride extended-release tablets)

80 mg Purdue Pharma L.P.

CII

(01

)20

35

90

11

48

02

07 LOT# XXXXXX EXP MM/YY

OxyContin®

(oxycodone hydrochloride extended-release tablets)

80 mg Purdue Pharma L.P.

CII

(01

)20

35

90

11

48

02

07 LOT# XXXXXX EXP MM/YY

OxyContin®

(oxycodone hydrochloride extended-release tablets)

80 mg Purdue Pharma L.P.

CII

(01

)20

35

90

11

48

02

07 LOT# XXXXXX EXP MM/YY

OxyContin®

(oxycodone hydrochloride extended-release tablets)

80 mg Purdue Pharma L.P.

CII

(01

)20

35

90

11

48

02

07 LOT# XXXXXX EXP MM/YY

OxyContin®

(oxycodone hydrochloride extended-release tablets)

80 mg Purdue Pharma L.P.

CII(0

1)2

03

59

01

14

80

20

7 LOT# XXXXXX EXP MM/YY

OxyContin®

(oxycodone hydrochloride extended-release tablets)

80 mg Purdue Pharma L.P.

CII

(01

)20

35

90

11

48

02

07 LOT# XXXXXX EXP MM/YY

OxyContin®

(oxycodone hydrochloride extended-release tablets)

80 mg Purdue Pharma L.P.

CII

Reference ID: 3646951

(b) (4)