How to get an NDC Number

How to Get an NDC Number

The National Drug Code (NDC) is a unique identifier assigned to medications in the United States, serving as a universal product identifier for human drugs. Managed by the Food and Drug Administration (FDA), the NDC system helps streamline drug tracking, billing, and inventory management. Whether you are a manufacturer, distributor, or healthcare provider, obtaining an NDC number is essential for compliance and market access. This guide provides a step-by-step breakdown of the process.

Understanding the NDC Number Structure

An NDC number consists of three segments in a 10-digit format: 1. Labeler Code (First Segment): Assigned by the FDA to the manufacturer or distributor (4 or 5 digits). 2. Product Code (Second Segment): Identifies the specific drug, strength, dosage form, and formulation (3 or 4 digits). 3. Package Code (Third Segment): Indicates the package size and type (1 or 2 digits).

The format can appear as 4-4-2, 5-3-2, or 5-4-1, depending on the labeler’s assignment.

Who Needs an NDC Number?

Entities that require an NDC number include: – Pharmaceutical manufacturers introducing new drugs. – Repackagers modifying existing drug packaging. – Private-label distributors selling drugs under their brand. – Over-the-counter (OTC) drug marketers (if not covered under a previous NDC).

Steps to Obtain an NDC Number

1. Determine Eligibility Before applying, confirm whether your product qualifies for an NDC. Prescription drugs, OTC medications, and biological products generally require one, while some compounded drugs or veterinary products may not.

2. Register with the FDA If you are a new manufacturer or distributor, you must first register your facility with the FDA. This involves: – Submitting facility information via the FDA Unified Registration and Listing System (FURLS). – Paying the annual registration fee (if applicable). – Designating an official correspondent for communication.

3. Request a Labeler Code The labeler code is the first segment of the NDC. To obtain one: – Submit a Labeler Code Request Form via the FDA’s Structured Product Labeling (SPL) system. – Provide company details, including DUNS number and FDA registration number. – Await approval, which typically takes 2–4 weeks.

4. Assign Product and Package Codes Once you have a labeler code, you can create the remaining segments internally. Follow FDA guidelines to ensure uniqueness: – Product Code: Reflects the drug’s active ingredients, strength, and dosage form. – Package Code: Differentiates packaging (e.g., bottle vs. blister pack).

5. Submit Drug Listing Information After assigning the full NDC, you must list the product with the FDA using the SPL format. This includes: – Drug name, ingredients, and strength. – Dosage form and route of administration. – Packaging details and NDC number. – Labeling and prescribing information.

Submit via the FDA Electronic Submissions Gateway (ESG) or through a third-party submission software.

6. Maintain Compliance NDC listings must be updated annually or whenever changes occur (e.g., new packaging or formulation). Failure to update may result in delisting.

Common Challenges and Solutions

– Rejected Applications: Ensure accurate data entry and compliance with FDA naming conventions. – Delays: Submit during non-peak periods and verify all supporting documents. – Changes in Product Details: Promptly update listings to avoid compliance issues.

Conclusion

Obtaining an NDC number is a critical step for drug manufacturers and distributors to operate legally in the U.S. market. By following FDA guidelines, registering your facility, and accurately listing your products, you can secure an NDC efficiently. Regular updates and adherence to regulatory requirements will ensure ongoing compliance and smooth market operations. Always consult the FDA’s latest guidance or a regulatory expert if uncertainties arise during the process.