Stalled by Drug Listing Issues?
We Clear the Path.
The FDA drug listing process is more than just a requirement; one small mistake can delay your launch and trigger costly setbacks.
At Registrar Corp, we ensure your drug listings are accurate, fully compliant, and submitted correctly the first time.
3,000+ Drug Manufacturers Trust Registrar Corp
Which Products Must Comply With FDA Drug Listing Requirements? Who’s Responsible?
FDA Drug Product Listing is required for U.S. and foreign companies that manufacture, repack, or relabel drug products for commercial distribution in the United States. This includes:
Each product strength, dosage form, and package configuration must be listed separately, and updates must be submitted when changes occur.
What You Might Be Overlooking
Many companies mistakenly believe that registration alone is sufficient for US market entry. However, FDA requires that every individual drug product be listed in Structured Product Labeling (SPL) format and submitted via the FDA CDER Next Gen Portal.
Failure to meet FDA Drug Listing requirements such as incorrect labeler codes, product identifiers, or packaging details can result in silent rejections without notification.
Registrar Corp ensures listings meet FDA formatting, validation, and labeling standards so your products stay compliant and on the market.
How the Drug Listing Process Works
Listing management, simplified:
1. Assess Listing Scope
We determine how many drug listings are needed based on product strengths, dosage forms, and packaging variations.
2. Create Structured Product Labeling (SPL)
You provide ingredients, labeler codes, route of administration, and marketing details.
3. Collect Product Data
You provide ingredients, labeler codes, route of administration, and marketing details.
4. Submit via FDA CDER Next Gen Portal
Listings are transmitted through FDA’s secure portal and validated for schema accuracy.
5. Monitor and Maintain Compliance
We provide confirmation and track your drug listings for annual renewal or required updates.
What You Gain
Labeler Code and NDC Review
Prevents format and duplication errors
Ongoing Monitoring
Recertification reminders and update tracking
FDA-Compliant SPL Files
Built to meet schema and validation standards
Real-Time Submission Support
Expert handling via the FDA CDER Next Gen Portal
Full Audit Trail
Document backup – securely store (ISO 27001) your docu ments for easy audit retrieval
Common FDA Drug Listing Challenges
- Submitting outdated or incorrectly formatted SPL files
- Using placeholder data or missing package details
- Duplicate or invalid NDCs
- Failing to update listings after formulation or packaging changes
- Missing annual recertification deadlines
Registrar Corp helps eliminate these risks by managing every aspect of your Drug Listing.
Why Choose Registrar Corp?
End-to-End drug listing support from data collection to FDA submission
In-house Regulatory Experts with 20+ years of FDA compliance experience
24/7 Client assistance across time zones and urgent needs
Trusted globally, supporting 30,000+ FDA-regulated companies
Real-time dashboard providing visibility into your listing status and renewals