1972 – The Drug Listing Act mandates all registered drug firms to provide the FDA with the most recent or updated list of all medications made, prepared, propagated, compounded, or processed for commercial distribution. The definition and rules for various drugs and their registration are provided under Section 510 (Federal Food, Drug, and Cosmetic Act) and Section 360 (Title 21) of the United States Code (USC). This is where the NDC idea comes into play.

Definition of NDC

The National Drug Code (NDC) is a three-part number used to identify and report drug items. FDA is responsible for publishing NDC numbers and submitting the published information as part of the NDC Directory listing information. The information supplied during the listing procedure, the NDC number, and the NDC Directory are used in the Act’s administration and enforcement. In addition, the NDC Directory is frequently updated to keep track of newly produced and authorized medicines.

Structure of NDC Number

The FDA follows a specific format/structure when giving an NDC number to a particular medicine to make the NDC numbers consistent, universal, and unique for each drug. Each NDC number has a unique 10-digit number with three segments:

  • Labeler
  • Product
  • Trade Package

         The Labeler Code:

As defined by the FDA, a labeler is any company that produces (including re-packers or re-labelers) or distributes (under its name) the medication.

         The Product Code:

It distinguishes a specific strength, dosage form, and medication composition for a particular company. As a result, various formulations or powers of the same formulation should be allocated to different product codes. This means that, even though the identical formulations of a drug product transmit various active component strengths to the receiver, they should be allocated separate product numbers. Furthermore, drug goods with the same formulation but distinct product features that identify one drug product version from another cannot be assigned the same product code under the same NDC labeler code.

         The Package Code:

It specifies the sizes and kinds of packages. Different package codes distinguish between quantitative and qualitative aspects of the product packaging. Therefore, the firm assigns both the product and package codes.

It is crucial to remember that, according to the FDA, an NDC number may conform to any of the following configurations:

  • 4-4-2: Labeler code of 4 digits, product code of 4 digits, and packaging code of 2 digits.
  • 5-3-2: Labeler code is 5 digits, product code is 3 digits, and package code is 2 digits.
  • 5-4-1: Labeler code is 5 digits, product code is 4 digits, and package code is 1 digit.

The labeler must create and submit an “NDC Labeler code request SPL” to FDA to get the NDC Labeler code. The FDA will not accept submissions on paper or by e-mail. The labeler must submit the SPL using the ESG or CDER Direct Portal. We are just a call away to give you more information regarding the NDC number.