Overview
The National Drug Code (NDC) is a unique numerical identifier used in the U.S. for prescription, over-the-counter, and insulin drug products. It consists of three segments and is required for regulatory, packaging, and billing purposes.
NDC Structure and Segments
- The NDC is a 10- or 11-digit code with three segments: labeler, product, and package.
- The first segment (labeler code) is assigned by the FDA to manufacturers, repackagers, or distributors.
- The product code (second segment) identifies the drug’s specific strength, dosage form, and formulation.
- The package code (third segment) indicates package sizes and types.
- Labelers assign the product and package codes.
NDC Formatting and Examples
- Common formats for the 10-digit NDC are 4-4-2, 5-3-2, or 5-4-1.
- Example: Prozac (20 mg, 100-count) NDC is 0777-3105-02 (labeler: Dista Products Co.).
- For billing, NDCs may be converted to an 11-digit 5-4-2 format by padding with leading zeros as needed.
Usage, Directory, and Accessibility
- The NDC Directory contains information on all FDA-listed human drug products.
- Only drugs with electronic listings (SPL) submitted to FDA are included since June 2011.
- The FDA maintains a searchable online NDC database; NDCs are found on packaging and in labeling inserts.
- Apps and pill identification tools also provide NDC lookup.
Exclusions and Non-Listed Products
- Products not listed may be non-drugs, discontinued, or not fully registered electronically.
- Compounded drugs by outsourcing facilities may be assigned NDCs but are not required to do so.
Billing and 11-Digit NDCs
- Many payors and CMS require an 11-digit NDC (no hyphens or spaces), often in a 5-4-2 format.
- Conversion from 10 to 11 digits involves adding zeros to the shortest code segment.
- NDC use in billing varies by payor; vaccines may be excluded from NDC billing by some Medicaid plans.
Future Changes and 12-Digit NDC Proposal
- The FDA anticipates running out of 5-digit labeler codes by around 2033.
- A proposed rule would change the NDC to a standard 12-digit, 6-4-2 format to simplify processes.
Recommendations / Advice
- Always verify NDC requirements with payors before claim submission, as rules can differ.
- For drug identification or NDC questions, consult pharmacists or use FDA and Drugs.com resources.