The National Drug Code (NDC) is a unique identifier for medicines in the United States, assigned by the U.S. Food and Drug Administration (FDA). Click here to obtain an NDC for a drug

1. Register the Establishment

Our USFDA agent ensures that your drug manufacturing or distribution establishment is registered with the FDA. This is a mandatory requirement under the Drug Listing Act of 1972.

• Online Registration: Online registration is called the Electronic Submissions Gateway (ESG).
• Renewal: Registration must be renewed annually between October 1st and December 31st.

2. List the Drug

Once the establishment is registered, our team needs to get the list of each drug from the FDA. The NDC is generated as part of this drug listing process.

• Electronic Listing: FDA’s Electronic Drug Registration and Listing System (eDRLS).
• Labeler Code: Our USFDA expert will obtain a labeler code from the FDA if you don’t already have one. This is the first segment of the NDC and identifies the company.

3. Submit the Required Information

When listing a drug, provide comprehensive details, including:

• Drug Name: The proprietary and non-proprietary names.
• Dosage Form and Strength: The form in which the drug is administered (e.g., tablet, injection) and its strength.
• Route of Administration: How the drug is administered (e.g., oral, intravenous).
• Packaging Information: Details about how the drug is packaged.
• Drug Label: Submit a copy of the drug label.

4. Compliance with SPL Format

By submitting the drug listing information in the Structured Product Labeling (SPL) format,. The SPL is an XML-based format that ensures standardized and structured data submission.

5. Receive the NDC

After successful submission and review by the FDA, an NDC will be assigned to your drug product. This code consists of three segments:

• Labeler Code: Identifies the manufacturer or distributor.
• Product Code: Identifies the specific drug, including its strength, dosage form, and formulation.
• Package Code: Identifies the package sizes and types.

6. Maintain and Update

Our team regularly updates your drug listing information with the FDA to ensure compliance and accuracy. Notify the FDA agent of any changes to the drug’s formulation, labeling, or packaging.

For more detailed instructions, you can connect with our USFDA expert on drug registration and listing or email us on support@regpro.us