21 CFR 207.35 -- What changes require a new NDC? (2024)

FAQs

21 CFR 207.35 -- What changes require a new NDC? ›

§207.35 What changes require a new NDC? (a) Once an NDC has been assigned by FDA, the registrant must propose a new and unique NDC for a drug when there is a change, after the drug is ini- tially marketed, to any of the informa- tion identified in paragraphs (b) and (c) of this section.

A new NDC must be proposed to FDA for assignment through an updated listing in accordance with § 207.57. (6) The drug's distinguishing characteristics such as size, shape, color, code imprint, flavor, and scoring (if any).

11-digit NDC

Submit the NDC in its 5-4-2 digit format: XXXXX-XXXX-XX. Some packages may display fewer than 11 digits. In this case, put zeros in in the proper position in front of the existing numbers when billing. Please note: For ease of reading, this page shows NDCs with hyphens between the segments.

Drugs are identified and reported using a unique, three-segment number called the National Drug Code (NDC) which serves as the FDA's identifier for drugs. FDA publishes the listed NDC numbers in the NDC Directory which is updated daily.

An obsolete NDC means that the manufacturer of the drug no longer makes the drug in that form and that the given National Drug Code (for that drug) has been replaced or discontinued by the manufacturer. But just because a drug's NDC is deemed as obsolete does not necessarily mean that the drug is expired.

FDA is proposing to change the NDC to 12 digits in length with three distinct and consistent segments and one uniform format. Additionally, FDA is proposing to revise the drug product barcode label requirements.

For example, the same drug may be produced by many different manufacturers or the same drug may have different dosages. The NDC code would be unique for all of them and can help you distinguish between those result results.

NDC Number

Each listed drug product listed is assigned a unique 10-digit, 3-segment number. This number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA.

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. The code is present on all nonprescription (OTC) and prescription medication packages and inserts in the US.

The NDC is reported in an 11-digit format, which is divided into three sections. The first five digits indicate the manufacturer or the labeler; the next four digits indicate the ingredient, strength, dosage form and route of administration; and the last two digits indicate the packaging.

What is NDC update? ›

NDCs embody efforts by each country to reduce national emissions and adapt to the impacts of climate change. The Paris Agreement requires each of the 193 Parties to prepare, communicate and maintain NDCs outlining what they intend to achieve. NDCs must be updated every five years.

(a) Once an NDC has been assigned by FDA, the registrant must propose a new and unique NDC for a drug when there is a change, after the drug is initially marketed, to any of the information identified in paragraphs (b) and (c) of this section.

The Drug Name and National Drug Code (NDC) Reference Data is a reference tool for Applicable Manufacturers (AMs) and Applicable Group Purchasing Organizations (GPOs), hereafter collectively referred to as reporting entities, to validate Drug Name and NDC information before reporting payments to the Open Payments system ...

Relisting and New NDC Numbers. For a change only in the trade package, firms may revise the Package Code segment without assigning a new Product Code segment. Firms may reassign the NDC code for a discontinued drug to a new drug.

On drug packaging, many National Drug Code (NDC) numbers are displayed in a 10-digit but correct billing of an NDC number requires 11 digits in a 5-4-2 format. The conversion from 10 digits to 11 digits requires the placement of an extra zero based on the 10-digit format.

Proper billing of an NDC requires an 11-digit number in a 5-4-2 format. Converting NDCs requires a stregically placed zero, depending on the 10-digit format. The following table shows common 10-digit NDC formats indicated on packaging and the appropriate conversion to an 11-digit format.

On drug packaging, many National Drug Code (NDC) numbers are displayed in a 10-digit but correct billing of an NDC number requires 11 digits in a 5-4-2 format. The conversion from 10 digits to 11 digits requires the placement of an extra zero based on the 10-digit format.