Knowledge Base
Official documentation, tools, and community resources for NDC12
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.
View details →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)."
View details →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.
View details →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.
View details →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.
View details →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.
View details →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..."
View details →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)
View details →FDA Proposed NDC12 Rule Published
Food and Drug Administration's (FDA) proposed amendment regarding the format of the National Drug Code (NDC).
View details →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)
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