Home NDC 72606-059 Denosumab-BMWO
Product NDC 72606-059
11-digit product format 726060059
Labeler code 72606
Product ID 72606-059_515e94c3-ab8d-4c35-8e7c-7083fd423d60
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 120 mg/1.7mL
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 Additional Listing Data#
Finished product Yes
Brand name base Denosumab-BMWO
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DENOSUMAB 120 mg/1.7mL
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 2717866 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 72606-059-01 Denosumab-BMWO 1 in 1 CARTON INJECTION 1 4 72606-059-01 Denosumab-BMWO 1.7 mL in 1 VIAL, SINGLE-USE INJECTION 1.7 4
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 · 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 Denosumab-BMWO DENOSUMAB-BMWO CELLTRION USA, Inc. d378622d-3a13-4918-ae18-3375cd10d270 2026-02-05 Warnings, Adverse reactions Exact identifier application number: BLA761404 ndc (product): 72606-059 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
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 2026-07-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 72606-059-01 72606005901 1 VIAL, SINGLE-USE in 1 CARTON (72606-059-01) / 1.7 mL in 1 VIAL, SINGLE-USE 2025-09-10 No No Current