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National Drug Code (NDC) Assignment Guide

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"National Drug Code (NDC) Assignment Guide"

Learn how to build and assign NDCs for your Rx or OTC drug product, the first step in electronically registering your product with FDA.

Part of the FDA’s requirement to electronically list drug products (Rx and OTC) includes the assignment of a National Drug Code (NDC). An NDC is a 10 digit number that uniquely identifies a drug product by stringing together three separate code segments. A complete NDC is made up of a labeler code, a product code and package code segment, with dashes between each segment.

This brief guide is intended to give you an overview of NDC structure and best practices for assigning NDCs to your product portfolio.

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