FDA Drug Listing Renewal

All drug manufacturing establishments registered with FDA must list each of their drug products. LMG prepares and submits complete drug listings including SPL data, labeling, and formulation information.

21 CFR Part 207Required After RegistrationAnnual Updates

FDA Drug Listing Renewal Requirement

Drug establishments (Domestic and Foreign) must list all drug products marketed in the USA under their labeler code immediately after establishment registration. If there is any change in the drug listing, it must be updated immediately or before June and December.

FDA Annual Drug Listing Update and Blanket Submission

If there is no change in drug information for all listed products, establishments can submit a blanket no change certification SPL to FDA, which will be considered as all product listings are current and updated.

Drug listing updates or blanket listing certification must be submitted every year during the renewal period, which is October 1st to December 31st.

Drug listings that are not updated during the renewal period will be considered inactive. The FDA may remove them from the DailyMed website and NDC directory.

Drug De-listing

Drug establishments must de-list any product that is no longer manufactured or marketed in the USA by submitting an updated SPL that includes a marketing end date for that product. De-listing keeps the labeler's drug listing accurate and prevents discontinued products from being reported as active in the FDA NDC Directory and on DailyMed. A product is de-listed by recording the date marketing ended rather than by deleting the listing record, which would mark the product as inactive while preserving its listing history.

LMG Can Help You With

Drug Listing with US FDA
Annual Drug Listing Update
De-listing of Inactive Drugs
Blanket No Change Certification

Drug Listing Services

LMG handles complete drug product listing submissions — initial listings, annual updates, and listing renewals for all drug product types.

Initial Drug Listing

Preparation and submission of your complete drug product listing to FDA — including NDC product codes, active and inactive ingredients, dosage form, and labeling.

Annual Drug Listing Update

Drug listings must be updated annually between October 1 and December 31. We manage your update submission — including any formulation or labeling changes.

Drug Listing for OTC Products

Specialized drug listing services for OTC monograph products — covering submission of complete NDC product structure, drug facts panel data, and distribution information.

SPL Submission

Structured Product Labeling (SPL) preparation and submission to FDA through the electronic submission gateway — the required format for all drug listings.

How It Works

We manage the entire process from start to finish — so you can focus on your business.

Listing Data Collection

We collect all required drug product data — active/inactive ingredients, dosage form, route of administration, NDC codes, and complete labeling.

SPL Preparation

We prepare the complete Structured Product Labeling (SPL) submission package in FDA-required XML format.

FDA Submission

We submit your drug listing through the FDA Electronic Submissions Gateway (ESG) and confirm receipt.

Confirmation & Monitoring

You receive confirmation of your drug listing. We monitor for any FDA queries and manage annual update deadlines.

Frequently Asked Questions

Common questions about this FDA service.

When must drugs be listed with FDA?

Drug products must be listed within 3 days of the establishment’s initial FDA registration. Listings must then be updated annually between June and December.

What information is required for drug listing?

Drug listing requires the NDC code, proprietary and established name, dosage form, route of administration, active and inactive ingredients, labeling, and distribution information.

Is drug listing required for imported drugs?

Yes. All drug products imported into the U.S. must be listed by the registered establishment responsible for the product.

What is SPL format?

Structured Product Labeling (SPL) is the FDA-required electronic format for drug listing submissions — an XML-based standard that FDA processes through its Electronic Submissions Gateway.