Knowledge Base

Official documentation, tools, and community resources for NDC12

Community

NDC12 Readiness Planning Guide

The NDC12 Readiness Planning Guide is a practical implementation guide for organizations preparing for the FDA’s transition to the 12-digit National Drug Code (NDC12). It covers planning guidelines, project phases, industry dependencies, and readiness planning approaches to help organizations build a realistic implementation roadmap for the March 2033 deadline.

Implementation

Document

Published : Jun 2026

FDA

FDA’s Final Rule on NDC12

FDA’s final rule regarding the 12-digit format for the national drug code (NDC12). The rule outlines a “…seven-year period before the rule takes effect (March 5, 2026 – March 6, 2033).”

Awareness

Document

Published : Mar 2026

Community

When Does the 10-Digit NDC Expire?

The FDA has not announced a fixed expiration date for the 10-digit NDC format. This article explains why the countdown uses 2032 and 2037 as the estimated dates, based on FDA regulatory timelines and projections.

Awareness

Document

Published : Jan 2026

FDA

FDA Video: Future Format of the NDC

This presentation provides an overview of the proposed rule revising the NDC format (NDC12). The session described the proposed implementation timeline for the new NDC format changes. The discussion offered insights into upcoming regulatory changes and their implications for drug identification and labeling requirements.

Awareness

Video

Published : Aug 2025

FDA

FDA Timeline for Finalized NDC12 Format

FDA’s latest 2026 Schedule to finalize NDC12. NOTE – This date is expected to extend further due the government shutdown in 2025.

Awareness

Document

Published : Jan 2025

FDA

FDA Slides – Format of the NDC

FDA slide deck published Sep 2023, summarizing the current NDC10 and the reasons/requirements for NDC12. This is an excellent overview of the NDC10 and NDC12. If you want slides and graphics from the authoritative source (i.e., FDA), this is the place to start.

Awareness, Implementation

Document

Published : Apr 2023

FDA

FDA Impact Analysis of NDC12

Mandatory FDA report to assess the “…anticipated costs and benefits (of NDC12)… that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more…”

Awareness, Implementation

Document

Published : Dec 2022

FDA

FDA Video – Revising the NDC Format

FDA webinar discussing the proposed rule, Revising the National Drug Code Format and Drug Label Barcode Requirements which is intended to minimize the impact of FDA running out of ten-digit national drug codes (NDC10) by adopting a single, uniform 12-digit format for FDA-assigned NDCs (NDC12)

Awareness

Video

Published : Nov 2022

FDA

FDA Proposed NDC12 Rule Published

Food and Drug Administration’s (FDA) proposed amendment regarding the format of the National Drug Code (NDC).

Awareness

Document

Published : Jul 2022

FDA

FDA Public Hearing: Future Format of the NDC

The FDA held a public hearing on November 5, 2018, regarding the future format of the National Drug Code (NDC)

Awareness

Document

Published : Nov 2018