Drug Listing
$149 per product
SPL-format drug product listing for each drug sold in the United States. Required under 21 CFR Part 207 for all foreign drug manufacturers.
What's included
- ✓ SPL (Structured Product Labeling) drug listing preparation
- ✓ Drug name, NDC number, and labeler information
- ✓ Active ingredient, strength, and dosage form filing
- ✓ Product listing confirmation in FDA's drug database
- ✓ Update filings when product details change
How It Works
Provide product details
Share your product name, active ingredients, dosage form, route of administration, and packaging details. An NDC Labeler Code and established registration are required prerequisites.
We prepare the SPL listing
We prepare the Structured Product Labeling (SPL) document and submit your drug listing to FDA's CDER drug database under 21 CFR Part 207.
Listing confirmed
Your drug product appears in FDA's drug listing database. NDC numbers are now active for each listed product. Listings must be updated when product details change.
Common questions
What is drug listing and is it required?+
Drug listing is the process of registering each individual drug product with FDA under 21 CFR Part 207. If you manufacture or distribute a drug product in the US, each product must be listed. This is separate from — and in addition to — facility registration.
What is SPL format?+
SPL (Structured Product Labeling) is the XML-based format FDA requires for drug listing submissions. It encodes product information including ingredients, dosage form, labeling, and NDC numbers in a structured way that FDA's systems can process.
How often must drug listings be updated?+
Drug listings must be updated within 30 days of any change to the product, including changes to labeling, ingredients, packaging, or marketing status. We track listing status for our clients and handle all update filings.
Do I need an NDC Labeler Code before drug listing?+
Yes. Drug listing requires an NDC Labeler Code. The full NDC number for each product is constructed from your labeler code plus product-specific segments. If you don't have a labeler code yet, see our NDC Labeler Code service ($249).
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Need registration + NDC + listings together?
The Drug Full Setup + Listings bundle ($1,399) includes FEI, drug establishment registration, NDC Labeler Code, US Agent, and 5 drug listings in one package.