Every drug product marketed in the United States must be listed with the FDA and assigned a National Drug Code (NDC). Drug listings must be submitted through DRLS and kept current. We handle the full submission and maintenance process.
NDC Number Assignment
We assist with NDC labeler code application and assignment of product codes for each distinct drug product package size and type.
- NDC labeler code application
- Product & package code assignment
- Multi-product NDC management
- 10-digit NDC formatting guidance
Drug Listing Submission (DRLS)
We prepare and submit complete drug product listings through the FDA’s DRLS system, including all required ingredient and labeling information.
- Active & inactive ingredient listing
- Dosage form & route of administration
- OTC & prescription products
- Label text submission
Drug Listing Updates
Drug listings must be updated whenever there are changes to the product formulation, labeling, or marketing status. We maintain your listings on an ongoing basis.
- Formulation change updates
- Labeling revision submissions
- Discontinued product notifications
- Reintroduced product relisting
OTC Monograph Products
OTC drug products marketed under FDA monographs have specific listing requirements under the CARES Act. We help you navigate OTC monograph compliance.
- OTC monograph order compliance
- OTC drug listing under CARES Act
- Facility fee registration support
- Monograph product notifications
Ready to List Your Drug Product?
Don’t let an outdated NDC listing flag your product for FDA action. Let us handle the submission and keep it current.
Drug Product Listing FAQs
The National Drug Code is a unique number the FDA assigns to every drug product marketed in the United States. It identifies the labeler, the specific product, and the package size, and it must appear on labeling before the product can be legally sold.
Listings are submitted electronically through the FDA’s Drug Registration and Listing System (DRLS) using Structured Product Labeling (SPL) format. The submission includes ingredients, dosage form, route of administration, and labeling text.
Anytime there’s a change to formulation, labeling, or marketing status, including discontinuing or reintroducing a product. Listings that fall out of date can create discrepancies the FDA may flag during inspection or review.
Yes. The FDA finalized a rule in March 2026 moving from the current 10-digit NDC to a uniform 12-digit format. There’s a seven-year preparation period, so FDA continues assigning 10-digit NDCs through March 2033, with enforcement on the new format beginning after March 2036. We’ll help clients transition when the time comes.