Back to: Electronic Drug Registration and Listing (eDRLS) Using CDER Direct
Topics Covered
- NDC Reservation
- Future Format of the National Drug Code
- NDC Assignment to Drugs
Presenters
David Mazyck
Consumer Safety Officer
Drug Registration and Listing Branch (DRLB)
Division of Labeling, Registration, and Unapproved Drugs
Office of Unapproved Drugs & Labeling Compliance (OUDLC)
Center for Drug Evaluation & Research (CDER)
US Food and Drug Administration (FDA)
Leyla Rahjou-Esfandiary, PharmD
Branch Chief
Drug Registration and Listing Branch (DRLB)
Division of Labeling, Registration, and Unapproved Drugs
Office of Unapproved Drugs & Labeling Compliance (OUDLC)
Center for Drug Evaluation & Research (CDER)
US Food and Drug Administration (FDA)
Soo Jin Park, PharmD, MS
Lieutenant Commander , United States Public Health Service (USPHS)
Regulatory Officer, Drug Registration and Listing Branch (DRLB)
Division of Labeling, Registration, and Unapproved Drugs
Office of Unapproved Drugs & Labeling Compliance (OUDLC)
Center for Drug Evaluation & Research (CDER)
US Food and Drug Administration (FDA)
Abstract
These virtual conference presentations cover the essential aspects of National Drug Code (NDC) management, from reservation to future format changes and assignment rules. The NDC Reservation tool aids in pre-launch activities like label printing, allowing firms to reserve NDCs for up to two years to prevent formatting errors and assist contract manufacturers. It is not a prerequisite for actual listing and does not require package information. Looking ahead, the FDA is addressing the impending shortage of 5-digit labeler codes by proposing a transition to a 12-digit NDC format (6-4-2). This change, expected to have a delayed effective date and transition period, aims to create a single, consistent NDC format, eliminating confusion and potential medication errors caused by current multiple formats. Regarding NDC assignment, it is a unique identifier for drugs in U.S. commercial distribution and, once assigned, cannot be reused for a new product, even after discontinuation (unless the same discontinued drug resumes marketing). A new NDC is required for changes to drug characteristics like name, active ingredient, or dosage form, and different package types need distinct package codes. While NDC assignment does not denote drug approval, it is strongly encouraged for human-readable display on labels. Specific guidance is provided for co-packaged products (kits) and multi-level packaging to ensure correct NDC application.