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FDA Announces Proposed Rule Updating the Current 10-Digit NDC Format to a 12-Digit Standardized Format

On July 22, 2022, the FDA announced a proposed rule changing the current 10-digit NDC format to a 12-digit standardized format. This is due to the limited number of new 5-digit Labeler Codes estimated to run out in the next 10 to 15 years. Current regulations require a 5-digit Labeler Code, 3 to 4-digit Product …