national drug code primer

8/8/2019 National Drug Code Primer

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TMPharmaceutical Primer 

WHAT IS AN NDC?

NDC is an acronym for National Drug

Code. The NDC directory was established

by the US Food and Drug Administration

 to serve as a universal product identifier

for human drugs. Each drug product listed

under Section 510 of the Federal Food,

Drug and Cosmetic Act is assigned aunique 10 or 11-digit, 3-segment number.

This number, or NDC, identifies three

aspects of the drug, as illustrated below.

■ ■ ■ National Drug Code (NDC) Primer

PHARMACEUTICAL SERVICESTM

 Who We Are

Strong Pharmaceutical Services, a division of Strong Environmental, Inc., is the leading

provider of destruction services to the pharmaceutical industry. Our experienced

professionals manage and ensure the appropriate witnessed destruction of DEA

controlled substances, as well as proper disposition of RCRA hazardous and non-

hazardous finished goods and manufacturing wastes. When we take control of waste

materials at your shipping dock, they become our full responsibility.

Stron Pharmaceutical Services: Secure Pharmaceutical Destruction Solutions 

Strong Pharmaceutical Service

a division of Strong Environmental, Inc

6264 Crooked Creek Road Norcross, GA 30092

770.409.1500 800.778.766

www.StrongPharma.com Solutions@StrongPharma.com

© Copyright 2008,Strong Environmental, In

LABELER CODE PRODUCT CODE

PACKAGE CODE

LABELER CODE: Identifies the firm that

manufactures, repacks, or distributes

 that particular drug product.

PRODUCT CODE: Identifies a specific

strength, dosage form, and formulation

for a particular labeler.

PACKAGE CODE: Identifies package

size.

The NDC will be in one of the following

configurations: 4-4-2, 5-3-2, 5-4-1 or 5-4-2.

The example at bottom left illustrates the

5-4-2 format. Formats may include leading

zeros. Both the product and package

codes are assigned by the labeler.

WHAT DOES A “**” MEAN

AT THE END OF AN NDC?

The “**” indicates a bulk solid or bulk

liquid product. In the case of finished

goods, it is typically a single solid unit

dose (tablet, vial, capsule), or a ml of

liquid.

WHERE CAN I FIND

MORE INFORMATION ABOUT NDCs?

http://www.fda.gov/cder/ndc

REGULATED PHARMACEUTICALS CHART

As a service to the pharmaceutical

manufacturing and distribution

community, Strong publishes our

Regulated Pharmaceuticals Chart,

illustrated above right, which includes

 the contents of this primer, as well

as more information about hazardous

pharmaceutical wastes, regulatory

agencies, controlled substances, listed

chemicals and more.

To request a copy of the poster for your

reference, please contact Strong at

770.409.1500, or via e-mail at Solutions@

StrongServices.com.

To request a copy of the poster for your

reference, please contact Strong at