Home NDC 69448-021 OSVYRTI
Product NDC 69448-021
11-digit product format 694480021
Labeler code 69448
Product ID 69448-021_b22cd858-906b-4d8c-9925-24a5b7e16665
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name denosumab-desu
Dosage form INJECTION
Route SUBCUTANEOUS
Labeler Accord BioPharma Inc.
Application BLA761424
Marketing category BLA
Marketing start 2026-07-06
Substance DENOSUMAB
Active strength 60 mg/mL
Pharmacologic classes RANK Ligand Blocking Activity [MoA]; RANK Ligand Inhibitor [EPC]
Listing certified through 2027-12-31
Current FDA listing Yes openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base OSVYRTI
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DENOSUMAB 60 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4EQZ6YO2HI Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2746871 Internal RxNorm lookup 2746878 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761424 Osvyrti denosumab-desu 351(k) Interchangeable Rx 2026-06-01
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Status 69448-021-63 69448002163 1 SYRINGE in 1 CARTON (69448-021-63) / 1 mL in 1 SYRINGE 1 syringe 2026-07-06 0 Current