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Pharmaceutical Primer TM

■ ■ ■ National Drug Code (NDC) Primer

WHAT IS AN NDC? The NDC will be in one of the following


NDC is an acronym for National Drug configurations: 4-4-2, 5-3-2, 5-4-1 or 5-4-2.
Code. The NDC directory was established The example at bottom left illustrates the
by the US Food and Drug Administration 5-4-2 format. Formats may include leading
to serve as a universal product identifier zeros. Both the product and package
for human drugs. Each drug product listed codes are assigned by the labeler.
under Section 510 of the Federal Food,
Drug and Cosmetic Act is assigned a WHAT DOES A “**” MEAN
AT THE END OF AN NDC?
unique 10 or 11-digit, 3-segment number.
The “**” indicates a bulk solid or bulk
This number, or NDC, identifies three
liquid product. In the case of finished
aspects of the drug, as illustrated below.
goods, it is typically a single solid unit
dose (tablet, vial, capsule), or a ml of
liquid.
PACKAGE CODE
PRODUCT CODE
LABELER CODE WHERE CAN I FIND
MORE INFORMATION ABOUT NDCs?
http://www.fda.gov/cder/ndc

REGULATED PHARMACEUTICALS CHART


As a service to the pharmaceutical To request a copy of the poster for your
LABELER CODE: Identifies the firm that reference, please contact Strong at
manufacturing and distribution
manufactures, repacks, or distributes 770.409.1500, or via e-mail at Solutions@
community, Strong publishes our
that particular drug product. StrongServices.com.
Regulated Pharmaceuticals Chart,
PRODUCT CODE: Identifies a specific illustrated above right, which includes
strength, dosage form, and formulation the contents of this primer, as well
for a particular labeler. as more information about hazardous
PACKAGE CODE: Identifies package pharmaceutical wastes, regulatory
size. agencies, controlled substances, listed
chemicals and more.

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 PHARMACEUTICAL SERVICES
TM

professionals manage and ensure the appropriate witnessed destruction of DEA


Strong Pharmaceutical Services
controlled substances, as well as proper disposition of RCRA hazardous and non- a division of Strong Environmental, Inc.
hazardous finished goods and manufacturing wastes. When we take control of waste 6264 Crooked Creek Road Norcross, GA 30092
materials at your shipping dock, they become our full responsibility. 770.409.1500 800.778.7664
www.StrongPharma.com Solutions@StrongPharma.com
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