denosumab-bmwo

Generic: denosumab-bmwo

Labeler: celltrion usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name denosumab-bmwo
Generic Name denosumab-bmwo
Labeler celltrion usa, inc.
Dosage Form INJECTION
Routes
SUBCUTANEOUS
Active Ingredients

denosumab 60 mg/mL

Manufacturer
CELLTRION USA, Inc.

Identifiers & Regulatory

Product NDC 72606-058
Product ID 72606-058_eccd7e42-9809-4553-84b1-149fa9ea128b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761404
Listing Expiration 2026-12-31
Marketing Start 2025-09-10

Pharmacologic Class

Established (EPC)
rank ligand inhibitor [epc]
Mechanism of Action
rank ligand blocking activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72606058
Hyphenated Format 72606-058

Supplemental Identifiers

RxCUI
2717855
UPC
0372606058014
UNII
4EQZ6YO2HI
NUI
N0000187055 N0000187054

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name denosumab-bmwo (source: ndc)
Generic Name denosumab-bmwo (source: ndc)
Application Number BLA761404 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 60 mg/mL
source: ndc
Packaging
  • 1 SYRINGE in 1 CARTON (72606-058-01) / 1 mL in 1 SYRINGE
source: ndc

Packages (1)

72606-058-01 1 SYRINGE in 1 CARTON (72606-058-01) / 1 mL in 1 SYRINGE

Ingredients (1)

denosumab (60 mg/mL)

Linked Drug Pages (1)

Denosumab-BMWO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "eccd7e42-9809-4553-84b1-149fa9ea128b", "openfda": {"nui": ["N0000187055", "N0000187054"], "upc": ["0372606058014"], "unii": ["4EQZ6YO2HI"], "rxcui": ["2717855"], "spl_set_id": ["7a449553-105c-46a1-bb72-849d8f5b81bd"], "pharm_class_epc": ["RANK Ligand Inhibitor [EPC]"], "pharm_class_moa": ["RANK Ligand Blocking Activity [MoA]"], "manufacturer_name": ["CELLTRION USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE in 1 CARTON (72606-058-01)  / 1 mL in 1 SYRINGE", "package_ndc": "72606-058-01", "marketing_start_date": "20250910"}], "brand_name": "Denosumab-BMWO", "product_id": "72606-058_eccd7e42-9809-4553-84b1-149fa9ea128b", "dosage_form": "INJECTION", "pharm_class": ["RANK Ligand Blocking Activity [MoA]", "RANK Ligand Inhibitor [EPC]"], "product_ndc": "72606-058", "generic_name": "denosumab-bmwo", "labeler_name": "CELLTRION USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Denosumab-BMWO", "active_ingredients": [{"name": "DENOSUMAB", "strength": "60 mg/mL"}], "application_number": "BLA761404", "marketing_category": "BLA", "marketing_start_date": "20250910", "listing_expiration_date": "20261231"}