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 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.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 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 2026-07-01
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