What Is Drug Listing?
Drug listing is the FDA's way of knowing exactly which drugs are in the U.S. market, who makes them, and where they're manufactured.
If you manufacture or distribute drugs in the U.S., you're required by law to register your establishment and list every drug product with the FDA. It's not optional—it's essential for marketing approval, safety tracking, and supply chain visibility.
Failure to meet FDA Drug Listing requirements like product identifiers, incorrect labeler codes, or packaging details can lead to rejections without notifications.
Why Is Drug Listing Important?
Drug inspections
Recalls and adverse event tracking
Post-market surveillance
Lifecycle updates and formulation changes
Import/export and distribution
Identifying unapproved or counterfeit products
Process Flow for Drug Listing
Establishment Registration
We register your facility with the FDA, including obtaining your unique FEI number if needed.
Initial Drug Listing
We collect your product data, including ingredients, labeler codes, marketing details, and route of administration, and convert the data into SPL format that meets FDA’s technical standards
Submission via ESG
We validate and submit all SPL-formatted files through FDA’s secure Electronic Submission Gateway (ESG).
Update Management
We handle all your biannual updates or any real-time changes—label updates, discontinuations, or packaging changes.
Compliance Tracking
We maintain audit trails and listing validation reports to ensure you are inspection-ready!
How Can We Help in Drug Listing?
We've helped drug manufacturers, private labellers, and contract manufacturers across the globe stay compliant with U.S. FDA drug listing regulations. Here's what makes us different:
Full SPL Formatting + Submission: We handle all technical aspects of SPL formatting and ensure successful submission.
Ongoing Update Management : We proactively manage all required updates to keep your listings current.
Timely Submissions—Every Cycle : We ensure you never miss critical June and December deadlines.
FDA eDRLS + ESG Expertise : Our team has deep knowledge of FDA electronic systems and requirements.
Services
| Service | Details |
|---|---|
| Establishment Registration with FDA |
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| Initial and Revised Drug Listing |
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| SPL Authoring and Validation |
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| Biannual Listing Updates (June & December) |
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| Labeler Code Assistance |
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| Post-submission Support and Tracking |
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| Submission to FDA Databases via ESG |
|
Regulatory Requirements for Drug Listing
Documents
- All data must be submitted in Structured Product Labeling (SPL) format
- Listings are published in multiple public databases:
FDA National Drug Code Directory
FDA Label Repository
NIH DailyMed
FDA Drug Establishment Registration Database
Your listings must include:
- NDC numbers and labeler codes
- Dosage form and route of administration, strength, and packaging details
- Manufacturer/labeler details
- Drug label content in SPL format
- Proprietary and non-proprietary name
Timeline
FDA listing is not just a one-time requirement. FDA drug listing requires initial submission within three days of establishment registration. You must update your listings twice a year, in June and December, or anytime there’s a change.
Regulatory Body
In the United States, the Food and Drug Administration (FDA) is the primary body responsible for approving and regulating drug listings. The FDA ensures that drugs, whether prescription, biosilimar, generic, or over over-the-counter, are safe, effective, and of high quality before they enter the market for their intended use.
Fees
The FDA charges annual fees for both establishment registration and drug product listing.
Validity
A “no changes” certification can be submitted once a year during the October 1 to December 31 registration renewal period if no updates are needed for any listed drugs. Thus, if there are no changes to a drug listing, a mandatory no-change certification is required annually.
Frequently Asked Questions(FAQs)
Is drug listing mandatory for all drug products?
Yes. Since 2017, it’s mandatory for NDAs, ANDAs, and commercial INDs. It’s also strongly recommended for non-commercial INDs and promotional materials.
Can you help with legacy submissions?
Yes, we convert older formats into fully compliant eCTD sequences and handle follow-ups.
Do you offer submission to the FDA directly?
Absolutely. We submit via ESG on your behalf—securely and efficiently.
What if I don’t have an application number yet?
No problem. We help you obtain a pre-assigned application number from the FDA.
Do you only serve US-based companies?
No, we support pharma companies globally that need to submit to U.S. regulatory authorities.
