Drug Listing
$149 per product
SPL drug listing for products made, repacked, relabeled, or salvaged for US commercial distribution where 21 CFR Part 207 applies.
What’s included
- ✓ SPL (Structured Product Labeling) drug listing preparation
- ✓ Drug name, NDC number, and labeler information
- ✓ Active ingredient, strength, and dosage form filing
- ✓ FDA submission response and listing-record review
- ✓ Later update or maintenance work scoped separately
How It Works
Confirm the listing roles and product details
Provide the product, labeling, packaging, responsible establishments, and marketing-company details. The labeler code must be assigned and confirmed; establishments performing registrable activities must be registered.
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.
Review the FDA record
We check the submitted SPL and FDA listing record. An NDC or listing does not itself mean FDA approved the product; applicable marketing requirements still apply.
Common questions
What is drug listing and is it required?+
Drug listing submits product details to FDA under 21 CFR Part 207. Registrants list drugs they manufacture, repack, relabel, or salvage for US commercial distribution; a private-label distributor's role should be assessed separately from the actual establishment activities. Listing does not constitute product approval.
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?+
Under 21 CFR 207.57, registrants review and update listings each June and December, report applicable new, discontinued, resumed, or materially changed information, and certify unchanged listings. FDA encourages updates when changes occur. The separate 30-day rule applies to changes in labeler-code contact, activity, or drug-type information; it is not a universal product-listing deadline. Ongoing update work is scoped separately.
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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Current NDC formats, company and establishment roles, the second confirmation SPL, and separate product listing.
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.