xgeva

Generic: denosumab

Labeler: amgen, inc
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name xgeva
Generic Name denosumab
Labeler amgen, inc
Dosage Form INJECTION
Routes
SUBCUTANEOUS
Active Ingredients

denosumab 120 mg/1.7mL

Manufacturer
Amgen, Inc

Identifiers & Regulatory

Product NDC 55513-730
Product ID 55513-730_a554622d-cdd7-4ab6-b581-a43fb6fbab45
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA125320
Listing Expiration 2026-12-31
Marketing Start 2010-11-18

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 55513730
Hyphenated Format 55513-730

Supplemental Identifiers

RxCUI
1046398 1046402
UPC
0355513730013
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 xgeva (source: ndc)
Generic Name denosumab (source: ndc)
Application Number BLA125320 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 120 mg/1.7mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 CARTON (55513-730-01) / 1.7 mL in 1 VIAL, SINGLE-USE
  • 1 VIAL, SINGLE-USE in 1 CARTON (55513-730-21) / 1.7 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (2)

55513-730-01 1 VIAL, SINGLE-USE in 1 CARTON (55513-730-01) / 1.7 mL in 1 VIAL, SINGLE-USE 55513-730-21 1 VIAL, SINGLE-USE in 1 CARTON (55513-730-21) / 1.7 mL in 1 VIAL, SINGLE-USE

Ingredients (1)

denosumab (120 mg/1.7mL)

Linked Drug Pages (1)

XGEVA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "a554622d-cdd7-4ab6-b581-a43fb6fbab45", "openfda": {"nui": ["N0000187055", "N0000187054"], "upc": ["0355513730013"], "unii": ["4EQZ6YO2HI"], "rxcui": ["1046398", "1046402"], "spl_set_id": ["628f0998-1206-4001-aeee-18133aa9f3bf"], "pharm_class_epc": ["RANK Ligand Inhibitor [EPC]"], "pharm_class_moa": ["RANK Ligand Blocking Activity [MoA]"], "manufacturer_name": ["Amgen, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-USE in 1 CARTON (55513-730-01)  / 1.7 mL in 1 VIAL, SINGLE-USE", "package_ndc": "55513-730-01", "marketing_start_date": "20101118"}, {"sample": false, "description": "1 VIAL, SINGLE-USE in 1 CARTON (55513-730-21)  / 1.7 mL in 1 VIAL, SINGLE-USE", "package_ndc": "55513-730-21", "marketing_start_date": "20250415"}], "brand_name": "XGEVA", "product_id": "55513-730_a554622d-cdd7-4ab6-b581-a43fb6fbab45", "dosage_form": "INJECTION", "pharm_class": ["RANK Ligand Blocking Activity [MoA]", "RANK Ligand Inhibitor [EPC]"], "product_ndc": "55513-730", "generic_name": "denosumab", "labeler_name": "Amgen, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "XGEVA", "active_ingredients": [{"name": "DENOSUMAB", "strength": "120 mg/1.7mL"}], "application_number": "BLA125320", "marketing_category": "BLA", "marketing_start_date": "20101118", "listing_expiration_date": "20261231"}