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 120 mg/1.7mL

Manufacturer
CELLTRION USA, Inc.

Identifiers & Regulatory

Product NDC 72606-059
Product ID 72606-059_ca365457-ee75-4e6d-b354-7fea922aedea
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761404
Listing Expiration 2027-12-31
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 72606059
Hyphenated Format 72606-059

Supplemental Identifiers

RxCUI
2717866
UPC
0372606059011
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
  • 120 mg/1.7mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 CARTON (72606-059-01) / 1.7 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

72606-059-01 1 VIAL, SINGLE-USE in 1 CARTON (72606-059-01) / 1.7 mL in 1 VIAL, SINGLE-USE

Ingredients (1)

denosumab (120 mg/1.7mL)

Linked Drug Pages (1)

Denosumab-BMWO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "ca365457-ee75-4e6d-b354-7fea922aedea", "openfda": {"nui": ["N0000187055", "N0000187054"], "upc": ["0372606059011"], "unii": ["4EQZ6YO2HI"], "rxcui": ["2717866"], "spl_set_id": ["d378622d-3a13-4918-ae18-3375cd10d270"], "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 VIAL, SINGLE-USE in 1 CARTON (72606-059-01)  / 1.7 mL in 1 VIAL, SINGLE-USE", "package_ndc": "72606-059-01", "marketing_start_date": "20250910"}], "brand_name": "Denosumab-BMWO", "product_id": "72606-059_ca365457-ee75-4e6d-b354-7fea922aedea", "dosage_form": "INJECTION", "pharm_class": ["RANK Ligand Blocking Activity [MoA]", "RANK Ligand Inhibitor [EPC]"], "product_ndc": "72606-059", "generic_name": "denosumab-bmwo", "labeler_name": "CELLTRION USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Denosumab-BMWO", "active_ingredients": [{"name": "DENOSUMAB", "strength": "120 mg/1.7mL"}], "application_number": "BLA761404", "marketing_category": "BLA", "marketing_start_date": "20250910", "listing_expiration_date": "20271231"}