How an NDC is built
An NDC is a 10-digit number in three parts:
| Labeler code | Assigned by FDA. Identifies the company named on the label. |
|---|---|
| Product code | Assigned by you. Identifies the strength, dosage form and formulation. |
| Package code | Assigned by you. Identifies the package size and type. |
So one product sold in three bottle sizes has three NDCs that share the same labeler and product codes.
How to get one
- Get a D-U-N-S number for your company and each establishment.
- Request a labeler code from FDA, submitted electronically in FDA's SPL format.
- Register the establishments that make, repack or relabel the drug. Establishments outside the U.S. name a U.S. Agent.
- List each drug. The listing assigns the product and package codes and includes the label.
Keeping NDCs up to date
- Drug listings are updated each June and December when anything has changed.
- A changed formula, strength or dosage form needs a new product code.
- Establishment registration is renewed every year between October 1 and December 31.
Questions
Do OTC drugs need an NDC?
Yes. OTC drugs such as sunscreens and hand sanitizers must be listed with FDA and carry an NDC. See FDA registration for OTC drugs.
Does a private label brand need its own labeler code?
If your company's name is on the label, you usually get your own labeler code and list the product under it. The manufacturer registers its establishment.
Does FDA charge for an NDC?
No. FDA does not charge for labeler codes, registration or listing. Some facilities pay separate FDA user fees, such as OTC monograph facility fees.
How Regovant can help
Regovant LLC registers drug establishments, obtains NDC labeler codes, lists products and acts as U.S. Agent for $369 a year, plus $169 per drug listing. See the drug registration service, all guides or prices.