{"id":313,"date":"2026-03-20T16:14:52","date_gmt":"2026-03-20T16:14:52","guid":{"rendered":"https:\/\/www.libertymanagement.us\/fda-news\/?p=313"},"modified":"2026-03-20T16:14:52","modified_gmt":"2026-03-20T16:14:52","slug":"ndc-reformation","status":"publish","type":"post","link":"https:\/\/www.libertymanagement.us\/fda-news\/2026\/03\/20\/ndc-reformation\/","title":{"rendered":"NDC REFORMATION"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">US FDA has finalized a rule to follow a uniform 12-digit\nformat for <a href=\"https:\/\/www.fdahelp.us\/fda-labeler-code.html\">NDC<\/a>\ninstead of current 10-digit format. This change is happening because FDA is\nrunning out of 5-digit labeler codes and will soon need to issue 6-digit codes\nto accommodate new manufacturers.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">As per new standard <a href=\"https:\/\/www.fdahelp.us\/fda-labeler-code.html\">NDC<\/a> numbers will be in\nstrict&nbsp;<strong>6-4-2 structure<\/strong>, totaling twelve digits:&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>Labeler\n     Code<\/strong>: six digits (identifies the manufacturer or distributor).<\/li><li><strong>Product\n     Code<\/strong>: four digits (identifies the specific strength, dosage form, and\n     formulation).<\/li><li><strong>Package\n     Code<\/strong>: two digits (identifies package size and type).&nbsp;<\/li><\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Existing 10-digit NDCs will change to this new format by\nadding&nbsp;<strong>leading zeros<\/strong>&nbsp;to the short segments as needed. For\nexample, a 5-3-2 format code like&nbsp;12345-678-90&nbsp;will\nbecome&nbsp;012345-0678-90.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The transition is planned with a long lead time to allow the healthcare industry to update their IT systems, insurances, databases, and labeling processes.\u00a0<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Below is the timeline for New NDC format\u00a0implementation<\/p>\n\n\n\n<table class=\"wp-block-table\"><tbody><tr><td>\n  <strong>Final Rule Published<\/strong>\n  <\/td><td>\n  March 5, 2026\n  <\/td><\/tr><tr><td>\n  <strong>Effective Date<\/strong>\n  <\/td><td>\n  <strong>March 7, 2033<\/strong>\n  <\/td><\/tr><tr><td>\n  <strong>Transition Period<\/strong>\n  <\/td><td>\n  March 7, 2033 \u2013 March 6, 2036\n  <\/td><\/tr><tr><td>\n  <strong>Full Enforcement<\/strong>\n  <\/td><td>\n  After March 7, 2036\n  <\/td><\/tr><\/tbody><\/table>\n\n\n\n<p class=\"wp-block-paragraph\">FDA is giving 3-year transition\nperiod starting from March 7, 2033, through March 6, 2036, for the\nmanufacturers, distributors, pharmacies, health care providers, and other\nagencies to update their system to manage 12-digit NDC number.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">As per new rule, both linear and\nnonlinear barcodes may be used to meet recognized standards like GS1. This\nallows a single 2D data matrix barcode to satisfy both NDC requirements and\nDrug Supply Chain Security Act (DSCSA) identifier rules.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">FDA will automatically update all <a href=\"https:\/\/www.fdahelp.us\/fda-drug-listing-renewal.html\">drug listing<\/a>\nSPL files to show 12-digit NDC format on the effective date. Drug manufacturers\nwill not need to resubmit or update their listings for the new NDC format. Drug\nmanufacturers are expected to their drug listings and labeling to reflect new\nNDC format.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">FDA has exempted certain biologics\nlike certain specified human cells, tissues, and cellular and tissue-based\nproducts to continue to use an FDA- approved alternative format.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"http:\/\/www.fdahelp.us\">Liberty Management Group Ltd<\/a>, provides assistance with <a href=\"https:\/\/www.fdahelp.us\/fda-drug-registration.html\">drugs establishment registration<\/a><a href=\"https:\/\/www.fdahelp.us\/ndc-labeler-code.html\">, NDC labeler code request<\/a>, <a href=\"https:\/\/www.fdahelp.us\/api-listing.html\">Drug listings<\/a> and <a href=\"https:\/\/www.fdahelp.us\/fda_registration\/us-fda-agents-requirements.html\">US agent service to foreign facilities<\/a>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Sudha S<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Regulatory Consultant<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Email : office@libertymanagement.us<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"http:\/\/www.fdahelp.us\">www.fdahelp.us<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>US FDA has finalized a rule to follow a uniform 12-digit format for NDC instead of current 10-digit format. This change is happening because FDA is running out of 5-digit labeler codes and will soon need to issue 6-digit codes to accommodate new manufacturers. As per new standard NDC numbers will be in strict&nbsp;6-4-2 structure, &hellip; <a href=\"https:\/\/www.libertymanagement.us\/fda-news\/2026\/03\/20\/ndc-reformation\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;NDC REFORMATION&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[26],"tags":[49,50],"class_list":["post-313","post","type-post","status-publish","format-standard","hentry","category-fda-registration-drug","tag-fda-drug-listings","tag-fda-ndc-labeler-codes"],"_links":{"self":[{"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/posts\/313","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/comments?post=313"}],"version-history":[{"count":2,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/posts\/313\/revisions"}],"predecessor-version":[{"id":315,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/posts\/313\/revisions\/315"}],"wp:attachment":[{"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/media?parent=313"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/categories?post=313"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/tags?post=313"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}