NDC three-segment identifier

Claim

The National Drug Code (NDC) is a unique three-segment identifier for listed drug products: labeler code (FDA-assigned), product code (strength/dosage form/formulation for that firm), and package code (package size/type). Current FDA-assigned NDCs are 10-digit numbers in 4-4-2, 5-3-2, or 5-4-1 configurations; billing systems often expand to an 11-digit HIPAA format with a leading zero. Do not treat future NDC digit-length reforms as PTCE trivia — focus on the three segments and reading the label.

Plain

NDC = labeler + product + package. 10-digit FDA forms vary (4-4-2 / 5-3-2 / 5-4-1); claims often use 11 digits. Read the label segments — don’t invent them.

Citations

1. FDA — National Drug Code Database Background Information (NDC 3 segments — labeler / product / package) — source
   

   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 second segment, the product code, identifies a specific strength, dosage form, and formulation for a particular firm. The third segment, the package code, identifies package sizes and types.

   retrieved 2026-09-08