As per the Drug Listing Act of 1972, all registered drug establishments are required to provide the Food and Drug Administration (FDA) with the latest or an updated list of all drugs manufactured, prepared, propagated, compounded, or processed by them for commercial distribution. Section 510 of the Federal Food, Drug, and Cosmetic Act and/or Section 360 under Title 21 of the United States Code (USC) provide the definition and guidelines for various drugs and their registration. This is where the term NDC comes in.
Definition of NDC
The term National Drug Code (NDC) refers to a unique three-segment number that is used to identify and report drug products. The Food and Drug Administration (FDA) is responsible to publish NDC numbers and submit the published information as part of the listing information in the NDC Directory. The information submitted as part of the listing process, the NDC number, and the NDC Directory are used in the implementation and enforcement of the Act. The NDC Directory is updated regularly to keep a record of newly manufactured and approved drugs.
To eliminate any confusion during the registration process the FDA in the Section 360— Registration of producers of drugs or devices under the Title 21—Food and Drugs of the United States Code (USC) outlines that:
- “The term ‘manufacture, preparation, propagation, compounding, or processing’ shall include repackaging or otherwise changing the container, wrapper, or labeling of any drug package or device package in furtherance of the distribution of the drug or device from the original place of manufacture to the person who makes final delivery or sale to the ultimate consumer or user.”
- “The term ‘name’ shall include in the case of a partnership the name of each partner and, in the case of a corporation, the name of each corporate officer and director, and the State of incorporation.”
Structure of NDC Number
To make the NDC numbers uniform, universal and unique for each drug, the FDA adheres to a particular format/structure while assigning an NDC number to a particular drug. Each NDC number is a unique 10-digit number that is divided into three segments— the labeler, product, and trade package size.
(Source: ttps://www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory)
- The Labeler Code: Assigned by the FDA, a labeler may refer to any firm that manufactures (including re-packers or re-labelers), or distributes (under its own name) the drug.
- The Product Code: It identifies a “specific strength, dosage form, and formulation of a drug for a particular 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 cannot share the same product code under the same labeler code.”
- The Package Code: It “identifies package sizes and types. 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.”
It is important to note that as per the FDA, a NDC number may adhere to any one of the configurations given following:
- 4-4-2: 4 digit labeler code, 4 digit product code, and 2 digit package code.
- 5-3-2: 5 digit labeler code, 3 digit product code and 2 digit package code.
- 5-4-1: 5 digit labeler code, 4 digit product code and 1 digit package code.
