What is NDC number?
NDC Number (National Drug Code Number) is a unique ten-digit number assigned to a drug product marketed in the USA. FDA uses NDC numbers to track drug products. Manufacturers and labelers need to refer to the NDC number in all communications with FDA.
Who requires NDC Number?
Drug manufacturers and labelers must request a labeler code from FDA. FDA will assign a unique 5-digit number to each labeler. The labeler needs to create a 10-digit NDC number and assign it to each drug while completing the drug listing process.
How to get NDC Number
In order to get the NDC Labeler code, the drug manufacturer or labeler must submit an SPL file to FDA requesting a new labeler code. After getting the labeler code request, FDA will assign the labeler code usually within a week, depending on the FDA schedule.
When is a New NDC Number Required?
The labeler must assign a new NDC number to the listed drug and need a new drug listing if:
(1) The drug’s established name or proprietary name changed.
(2) Any active pharmaceutical ingredient or the strength of any active pharmaceutical ingredient changed.
(3) A change in the dosage form.
(4) A change in the drug’s status between prescription and nonprescription.
(5) A change in the drug’s intended use.
(6) The characteristics such as size, shape, color, code imprint, flavor, scoring etc., are changed.
When is a New NDC Number Not Required?
If there is a change only to the package size or type or adding a new package to the existing listing, only the package code (last segment) needs to change and update the existing listing.
Can I use NDC Number for Marketing Purposes?
No, the NDC number cannot use for marketing purposes. Any wording or picture of the NDC number implying an FDA approval may result in misbranding of the product.