Q.What is NDC Code (National Drug Code)?
The NDC, or National Drug Code, is a unique 10-digit, 3-segment number. It is a universal product identifier for human drugs in the United States.
Drug products are identified and reported using a unique, three-segment number, called the National Drug Code (NDC), which serves as a universal product identifier for drugs.
The three segments are as follows:
First segment (Labeler Code):
The first segment is called as the labeler code, which is assigned by the FDA. A labeler is any firm that manufactures (including repackers or relabelers), or distributes (under its own name) the drug.
Second Segment (Product Code):
The second segment is called as the product code which identifies a specific strength, dosage form, and formulation of a drug for a particular firm (i.e, capsule, tablet, liquid).
This product code is assigned by the firm.
Different formulations or different strengths of the same formulation should be assigned different product codes. This means even if the same formulations of a drug product ultimately deliver different strengths of the active ingredient to the recipient, they should be assigned different product codes. Also, drug products that share the same formulation but have different product characteristics that clearly distinguish one drug product version from another can not share the same product code under the same labeler code.
The NDC will be in one of the following configurations:
4-4-2, 5-3-2, 5-4-1.
Third Segment (Package Code):
The third segment us called as the package code which identifies package sizes and types.
This package code is assigned by the firm.
Different package codes only differentiate between different quantitative and qualitative attributes of the product packaging.
Both the product and package codes are assigned by the firm however labeler code is assigned by the FDA.
Why this NDC Code is required?
The Drug Listing Act of 1972 requires registered drug establishments to provide the Food and Drug Administration (FDA) with a current list of all drugs manufactured, prepared, propagated, compounded, or processed by it for commercial distribution. (See Section 510 of the Federal Food, Drug, and Cosmetic Act (Act) (21 U.S.C. § 360)).
The FDA maintains a searchable database of all NDC codes on their website. FDA publishes the listed NDC numbers and the information submitted as part of the listing information in the NDC Directory which is updated daily.
The code is present on all nonprescription (OTC) and prescription medication packages and inserts in the US.
Example of NDC Code:
￼For example, the NDC for a 100-count bottle of XYZ capsules 50 mg is “12345-123-01″. The first segment of numbers identifies the labeler. In this case, the labeler code “12345” is for ABC Pharma Company, the labeler of XYZ capsules 50mg. The second segment, the product code, identifies the specific strength, dosage form (i.e, capsule, tablet, liquid) and formulation of a drug for a specific manufacturer. In our case, “123” identifies that this dosage form is a capsule. The third segment is the package code, and it identifies package sizes and types. Our example shows that the package code “01” for this bottle of XYZ drug identifies that 100 capsules are in the bottle.
Ref: US Food and Drug Administration