NDC & product identity

10-digit NDC

Definition

The form the FDA publishes, which may be 4-4-2, 5-3-2 or 5-4-1 depending on how the labeler's segments were assigned.

The FDA never required a uniform width, so the 10-digit code is ambiguous: 12345-678-90 could be read as 5-3-2 or, if the hyphens are stripped, as several other things. This ambiguity is the entire reason the 11-digit billing form exists.

Always convert from the hyphenated 10-digit code, never from the digits alone. Once the hyphens are gone the original segmentation cannot be recovered reliably.

11-digit NDCThe 5-4-2 billing form of an NDC, produced by padding a leading zero into whichever 10-digit segment is short.Definition 4-4-2 formatA 10-digit NDC with a four-digit labeler code; the leading zero goes into the first segment.Definition 5-3-2 formatA 10-digit NDC with a three-digit product code; the leading zero goes into the middle segment.Definition 5-4-1 formatA 10-digit NDC with a one-digit package code; the leading zero goes into the last segment.Definition

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5-4-2 format Kit (NDC)Labeler code Leading zero padding Listing expiration date Marketing end date Marketing start date N4 qualifier

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10-digit NDC

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