osenvelt

Generic: denosumab-bmwo

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

Drug Facts

Product Profile

Brand Name osenvelt
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 72606-038
Product ID 72606-038_d9c79d7b-64d3-4f8f-a97f-4337bf2b92a4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761404
Listing Expiration 2027-12-31
Marketing Start 2025-07-02

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 72606038
Hyphenated Format 72606-038

Supplemental Identifiers

RxCUI
2717866 2717873
UPC
0372606038016
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 osenvelt (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 (72606-038-01) / 1.7 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

72606-038-01 1 VIAL, SINGLE-USE in 1 CARTON (72606-038-01) / 1.7 mL in 1 VIAL, SINGLE-USE

Ingredients (1)

denosumab (120 mg/1.7mL)

Linked Drug Pages (1)

Osenvelt ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "d9c79d7b-64d3-4f8f-a97f-4337bf2b92a4", "openfda": {"nui": ["N0000187055", "N0000187054"], "upc": ["0372606038016"], "unii": ["4EQZ6YO2HI"], "rxcui": ["2717866", "2717873"], "spl_set_id": ["c5a5d750-80be-49cd-b4a6-c8a815956059"], "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 (72606-038-01)  / 1.7 mL in 1 VIAL, SINGLE-USE", "package_ndc": "72606-038-01", "marketing_start_date": "20250702"}], "brand_name": "Osenvelt", "product_id": "72606-038_d9c79d7b-64d3-4f8f-a97f-4337bf2b92a4", "dosage_form": "INJECTION", "pharm_class": ["RANK Ligand Blocking Activity [MoA]", "RANK Ligand Inhibitor [EPC]"], "product_ndc": "72606-038", "generic_name": "denosumab-bmwo", "labeler_name": "CELLTRION USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Osenvelt", "active_ingredients": [{"name": "DENOSUMAB", "strength": "120 mg/1.7mL"}], "application_number": "BLA761404", "marketing_category": "BLA", "marketing_start_date": "20250702", "listing_expiration_date": "20271231"}