Home NDC 72606-058 Denosumab-BMWO
Product NDC 72606-058
11-digit product format 726060058
Labeler code 72606
Product ID 72606-058_180d317f-8fa9-4e03-bc3e-756bcfbb4fd6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name denosumab-bmwo
Dosage form INJECTION
Route SUBCUTANEOUS
Labeler CELLTRION USA, Inc.
Application BLA761404
Marketing category BLA
Marketing start 2025-09-10
Substance DENOSUMAB
Active strength 60 mg/mL
Pharmacologic classes RANK Ligand Blocking Activity [MoA], RANK Ligand Inhibitor [EPC]
NDC exclude flag No
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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Denosumab-BMWO DENOSUMAB-BMWO CELLTRION USA, Inc. 7a449553-105c-46a1-bb72-849d8f5b81bd 2026-02-05 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA761404 ndc (product): 72606-058 Denosumab-BMWO DENOSUMAB-BMWO CELLTRION USA, Inc. d378622d-3a13-4918-ae18-3375cd10d270 2026-02-05 Warnings, Adverse reactions Exact identifier application number: BLA761404 Stoboclo DENOSUMAB-BMWO CELLTRION USA, Inc. 10b9eea3-bf70-4ff3-a0b9-54248cbfd156 2026-02-05 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA761404 Osenvelt DENOSUMAB-BMWO CELLTRION USA, Inc. c5a5d750-80be-49cd-b4a6-c8a815956059 2026-02-05 Warnings, Adverse reactions Exact identifier application number: BLA761404
Additional Listing Data#
Finished product Yes
Brand name base Denosumab-BMWO
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2717855 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72606-058-01 Denosumab-BMWO 1 in 1 CARTON INJECTION 1 4 72606-058-01 Denosumab-BMWO 1 mL in 1 SYRINGE INJECTION 1 4
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761404 Stoboclo denosumab-bmwo 351(k) Interchangeable Rx 2026-06-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72606-058-01 72606005801 1 SYRINGE in 1 CARTON (72606-058-01) / 1 mL in 1 SYRINGE 1 syringe 2025-09-10 No No Current