NDC Number

 How to get NDC Number?

NDC number is a 10-digit code that represents the labeler+drug+package size. the first 5 digits represent the labeler (the company) which is assigned by US FDA. the second segment represents the drug product and is assigned by the labeler. the third segment is for packaging type and size, which is also assigned by the labeler. There is no pre-assigned NDC number database on the FDA site; it is the labeler's responsibility to assign the 10-digit NDC number and maintain traceability.

information required for NDC number request are

Informations required for NDC Number request

• Labeler Name
• DUNS Number

    FDA uses the DUNS number to verify the establishment address.

• Contact Name & Address

    The address includes Street, City, State, Postal code, Country, Phone, and email.

• Labeler Address

    Address of the labeler, including Street, City, State, Postal code, and Country.

• Business Operation

    Identify the Type of business.

• Us Agent

    Each foreign establishment should have a US agent.

Source : https://www.fdahelp.us/ndc_number.html