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US drug packaging to adopt new 12-digit medicine code system
Yahoo Finance· 2026-03-13 09:21
Core Viewpoint - The FDA is transitioning the National Drug Code (NDC) system from a 10-digit to a uniform 12-digit format to standardize drug identification and support future growth in approved products [1][4]. Group 1: Transition Details - The new 12-digit NDC structure will be implemented on March 7, 2033, with a labeling transition period extending until March 2036 [2][7]. - All FDA-assigned NDC numbers for human and animal medicines will be converted to the new format, requiring updates from manufacturers, distributors, and healthcare providers [2][3]. Group 2: Rationale for Change - The existing 10-digit NDC system has varied segment lengths (4-4-2, 5-3-2, 5-4-1), leading to complexity in electronic systems and billing transactions [4]. - The FDA has indicated that the current system risks exhausting available labeler codes, necessitating a uniform format to enhance efficiency [4][5]. Group 3: New Structure Specifications - The new 12-digit NDC format will consist of a fixed 6-4-2 configuration: 6 digits for the labeler code, 4 digits for the product code, and 2 digits for the package code [6][8]. - This change aims to increase the number of available combinations and reduce inconsistencies in pharmaceutical data systems [5][6].