{"abstract":"The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to standardize the format of the National Drug Code (NDC). Under this final rule, all FDA-assigned NDCs will be required to be 12 digits in length with 3 distinct segments and 1 uniform format. The first segment is a 6-digit labeler code, the second segment is a 4-digit product code, and the third segment is a 2-digit package code. Additionally, we are revising the drug product barcode label requirements to permit the use of other data carriers that meet the standards of this final rule.","action":"Final rule.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2026/03/05/2026-04368.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"201","title":21},{"chapter":null,"citation_url":null,"part":"207","title":21}],"citation":"91 FR 10749","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective March 7, 2033.","disposition_notes":null,"docket_ids":["Docket No. FDA-2021-N-1351"],"dockets":[{"supporting_documents":[{"title":"Reference 8 - NDC-FRIA 2-20-26","document_id":"FDA-2021-N-1351-0064"},{"title":"Reference 7 - RTI (2015) Labeling Cost Model","document_id":"FDA-2021-N-1351-0063"},{"title":"Reference 6 - RAND Corp (2004)","document_id":"FDA-2021-N-1351-0062"},{"title":"Reference 5 - PRIA NDC Proposed Rule","document_id":"FDA-2021-N-1351-0061"},{"title":"Reference 4 - Nara S (2023)","document_id":"FDA-2021-N-1351-0060"},{"title":"Reference 3 - Carreiras M (2015)","document_id":"FDA-2021-N-1351-0059"},{"title":"Reference 2 - Molinaro (2010)","document_id":"FDA-2021-N-1351-0058"},{"title":"Reference 1 - Grissinger M (2017)","document_id":"FDA-2021-N-1351-0057"},{"title":"References 5 - RAND (2004), \"The Costs and Benefits of Moving to the ICD-10 Code Sets\"","document_id":"FDA-2021-N-1351-0008"},{"title":"References 4 - FDA, Preliminary Regulatory Impact Analysis, ‘‘Revising the National Drug Code Format and Drug Label Barcode Requirements\"","document_id":"FDA-2021-N-1351-0007"}],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2026-03-05","updated_at":"2026-03-05T09:58:43.632-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2021-N-1351-0056","allow_late_comments":false,"id":"FDA-2021-N-1351-0056","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":13,"id":"FDA-2021-N-1351","title":"Revising the National Drug Code Format and Drug Label Barcode Requirements"}],"document_number":"2026-04368","effective_on":"2033-03-07","end_page":10771,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/03/05/2026-04368.xml","html_url":"https://www.federalregister.gov/documents/2026/03/05/2026-04368/revising-the-national-drug-code-format-and-drug-label-barcode-requirements","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-04368?publication_date=2026-03-05","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-03-05/2026-04368/mods.xml","not_received_for_publication":null,"page_length":23,"page_views":{"count":9243,"last_updated":"2026-05-18 06:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-03-05/pdf/2026-04368.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-04368.pdf?1772631910","publication_date":"2026-03-05","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/03/05/2026-04368.txt","regulation_id_number_info":{"0910-AI52":{"issue":"202504","html_url":"https://www.federalregister.gov/regulations/0910-AI52/revising-the-national-drug-code-format-and-drug-label-barcode-requirements","title":"Revising the National Drug Code Format and Drug Label Barcode Requirements","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202504&RIN=0910-AI52&operation=OPERATION_EXPORT_XML","priority_category":"Substantive, Nonsignificant"}},"regulation_id_numbers":["0910-AI52"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 8 - NDC-FRIA 2-20-26","document_id":"FDA-2021-N-1351-0064"},{"title":"Reference 7 - RTI (2015) Labeling Cost Model","document_id":"FDA-2021-N-1351-0063"},{"title":"Reference 6 - RAND Corp (2004)","document_id":"FDA-2021-N-1351-0062"},{"title":"Reference 5 - PRIA NDC Proposed Rule","document_id":"FDA-2021-N-1351-0061"},{"title":"Reference 4 - Nara S (2023)","document_id":"FDA-2021-N-1351-0060"},{"title":"Reference 3 - Carreiras M (2015)","document_id":"FDA-2021-N-1351-0059"},{"title":"Reference 2 - Molinaro (2010)","document_id":"FDA-2021-N-1351-0058"},{"title":"Reference 1 - Grissinger M (2017)","document_id":"FDA-2021-N-1351-0057"},{"title":"References 5 - RAND (2004), \"The Costs and Benefits of Moving to the ICD-10 Code Sets\"","document_id":"FDA-2021-N-1351-0008"},{"title":"References 4 - FDA, Preliminary Regulatory Impact Analysis, ‘‘Revising the National Drug Code Format and Drug Label Barcode Requirements\"","document_id":"FDA-2021-N-1351-0007"}],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2021-N-1351","supporting_documents_count":13,"docket_id":"FDA-2021-N-1351","document_id":"FDA-2021-N-1351-0056","regulation_id_number":null,"title":"Revising the National Drug Code Format and Drug Label Barcode Requirements","checked_regulationsdotgov_at":"2026-03-06T18:55:04Z"},"regulations_dot_gov_url":null,"significant":false,"signing_date":null,"start_page":10749,"subtype":null,"title":"Revising the National Drug Code Format and Drug Label Barcode Requirements","toc_doc":"Revising the National Drug Code Format and Drug Label Barcode Requirements","toc_subject":null,"topics":["Drugs","Labeling","Reporting and recordkeeping requirements"],"type":"Rule","volume":91}