FDA Drug Listing Service

All drug establishments registered with FDA must list each of their drug products. LMG prepares and submits complete drug listings, including labeling, and drug facts information in SPL format via FDA ESG.

21 CFR Part 207Required After NDC AssignmentAnnual Updates

Drug Listing Services

Although the registrant is responsible for submitting the drug listing, both human and animal drugs marketed under a private label distributor’s (brand owner’s) name must be listed using an NDC that contains the private label distributor’s labeler code.

For human drugs, the registrant must also list every drug it manufactures, repacks, or relabels using an NDC that includes the registrant’s own labeler code, even if the product is marketed under the name or label of a private label distributor rather than the registrant’s own brand.

LMG handles end-to-end drug product listing submissions, including initial listings, annual updates, listing renewals, and delistings for all product types, including APIs, semi-finished products, homeopathic drugs, and animal drugs.

Initial Drug Listing

Preparation and submission of your complete drug product listing to FDA with all required information — including drug facts, active and inactive ingredients, dosage form, warnings, directions, and labeling.

Annual Listing Update

Drug listings must be updated annually between October 1st to December 31st. If there is no change in drug information for all listed products, establishments can submit a blanket no change certification. We manage your update submission

OTC Drug Listing

Specialized drug listing services for OTC monograph drug products — LMG handles the complete listing process using LMG SPLmatrix™, ensuring your drug product listings meet all FDA electronic submission requirements.

SPL Submission

SPL preparation and submission to FDA through the electronic submission gateway — the required format for all drug listings. LMG uses our proprietary software LMG SPLmatrix™ to ensure accurate, error-free submissions.

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 regulatory service.

When must drugs be listed with FDA?

Drug products must be listed within 3 calendar days after the initial registration of the establishment. Listings must then be updated annually between October 1 – December 31.

What information is required for drug listing?

Drug listing requires complete information about the drug, including the NDC code, proprietary and established names, dosage form, route of administration, active and inactive ingredients, packaging type, and labeling.

Is drug listing required for imported drugs?

Yes. All drug products imported into the U.S. must be listed by the labeler and/or the manufacturer 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.