The 10-Digit Identity.
Obtain your FDA Labeler Code, assign your NDC number, and list your drug product in the NDC Directory without touching a single line of XML.
Your FDA Labeler Code.
Before you can assign an NDC, you need a Labeler Code assigned by the FDA. This 5-digit number identifies your company as the manufacturer or distributor. We handle the application.
DUNS Integration.
You cannot list a drug without a valid DUNS number that matches FDA's FURLS database exactly. We synchronize your Dun & Bradstreet profile with FDA records to prevent rejection errors.
Segment Strategy.
5-3-2? 5-4-1? The format you choose determines how many products and package sizes you can register. We help you choose the right configuration for your portfolio.
Contract Manufacturing.
Using a CMO? The factory lists the bulk drug, but YOU (the Private Label Distributor) must list the finished product under your own NDC to sell it. We map the supply chain.
XML Translation.
FDA doesn't accept PDFs. Drug Listings must be submitted in Structured Product Labeling (SPL) format—a complex XML standard. Our engine converts your data instantly.
<id root='2.16.840.1...'/>
<code code='34391-3'/>
<title>Drug Label</title>
<author>
<assignedEntity/>
</author>
</document>
Active vs. Uncertified.
An expired listing makes your drug “misbranded” and subject to detention. We monitor your listing status daily to ensure it remains Active and Certified.
Homeopathic Listings.
Homeopathic products are unapproved drugs but MUST be listed with FDA. We ensure your active ingredients match the Homeopathic Pharmacopoeia (HPUS) standards.
Sync to DailyMed.
Once your SPL is accepted, it propagates to the NDC Directory and DailyMed (NLM). Doctors, pharmacists, and consumers rely on this data. We ensure it matches your label.
NDC to Barcode.
Your 10-digit NDC needs to be converted into a 12-digit UPC or DataMatrix for retail scanning. We provide the correct conversion logic for your packaging designer.
Monograph Match.
Most OTC drugs (sunscreen, sanitizer, analgesics) follow a Final Monograph. We verify your active ingredients match the GRASE (Generally Recognized As Safe & Effective) standards.
Drug + Device Kits.
Selling a First Aid Kit? You need a “Kit NDC” for the outer box, plus individual NDCs for the alcohol swabs and antibiotic ointments inside. We handle the hierarchy.
Certificate of Pharmaceutical Product.
Exporting your US-made drug? Foreign governments require an eCPP (FDA 3755) to prove it's listed and compliant in the USA. We facilitate the export certification.
Clear PREDICT.
FDA's PREDICT system scans every entry. If your NDC isn't active or your labeler code mismatches the manufacturer, your goods are held. We ensure data integrity at the port.
Warning Letter Defense.
FDA issues thousands of Warning Letters for “Unapproved New Drugs” due to listing errors. Our system flags risky claims and format errors BEFORE you submit.
Global Reach.
Are you a foreign manufacturer? You need a US Agent to complete your registration. We integrate the US Agent appointment directly into the listing workflow.
The Annual Cliff.
Drug Listings expire every year on December 31st. If you don't submit a “No Changes” certification or an update, your product is removed from the market. We automate this.
Blanket Certification.
Have 50 products with no changes? Don't update them one by one. Use our “Blanket No Changes Certification” tool to renew your entire portfolio in one click.
Platform vs. CDER Direct.
Stop fighting with government portals. Use a modern interface.
Get your NDC in 48 hours.
Stop fighting with XML files. Launch your drug product today.
Full Listing Support
Everything you need to launch and maintain your drug product.
SPL Conversion
Raw data to FDA-compliant XML.
DUNS Validation
Checking facility data consistency.
Label Audit
Checking for 'Drug Facts' compliance.
Frequently Asked Questions
Common questions about this regulatory requirement.
Secure Your Supply Chain.
Don't let a clerical error stop your shipment at the border. Join 2,800+ food companies who trust Assurentry for automated compliance.