Drug Listing & Registration — NDC, establishment, annual reporting.
FDA requires registered establishments to submit drug listing information in SPL format. Alnexia operates the full DRLS workflow — establishment registration, NDC labeler code reservation, initial and update listings, and annual reporting.
What we deliver
Establishment registration
Initial registration and yearly re-registration of domestic and foreign establishments.
NDC labeler code
Labeler code reservation and management across multiple subsidiaries.
Initial listing
Marketed status, packaging configuration and active/inactive ingredients submitted in SPL.
Updates & corrections
Marketing status changes, NDC changes, withdrawals and corrections handled within FDA timelines.
Annual reporting
Annual update window managed proactively, with Blanket No Change Certification where applicable.
Self-identification
Generic Drug User Fee Act (GDUFA) facility self-identification SPLs.
Artefacts you receive
- Establishment registration SPL
- NDC labeler code & listings SPL
- Annual report or BNCC
- ESG transmission receipts
Sourced from regulators and industry leaders
- FDA — Drug Registration and Listing System (DRLS) — U.S. FDA
- FDA — National Drug Code Directory — U.S. FDA
Ready to scope this work?
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