NDC 55513-730

XGEVA

Denosumab

XGEVA is a Subcutaneous Injection in the Human Prescription Drug category. It is labeled and distributed by Amgen Inc. The primary component is Denosumab.

Product ID55513-730_201abd85-c4ed-424f-8e79-ca1c34368d06
NDC55513-730
Product TypeHuman Prescription Drug
Proprietary NameXGEVA
Generic NameDenosumab
Dosage FormInjection
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2010-11-18
Marketing CategoryBLA / BLA
Application NumberBLA125320
Labeler NameAmgen Inc
Substance NameDENOSUMAB
Active Ingredient Strength120 mg/1.7mL
Pharm ClassesRANK Ligand Inhibitor [EPC],RANK Ligand Blocking Activity [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 55513-730-01

1 VIAL, SINGLE-USE in 1 CARTON (55513-730-01) > 1.7 mL in 1 VIAL, SINGLE-USE
Marketing Start Date2010-11-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55513-730-01 [55513073001]

XGEVA INJECTION
Marketing CategoryBLA
Application NumberBLA125320
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2010-11-18

Drug Details

Active Ingredients

IngredientStrength
DENOSUMAB120 mg/1.7mL

OpenFDA Data

SPL SET ID:628f0998-1206-4001-aeee-18133aa9f3bf
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1046402
  • 1046398
  • Pharmacological Class

    • RANK Ligand Inhibitor [EPC]
    • RANK Ligand Blocking Activity [MoA]

    Medicade Reported Pricing

    55513073001 XGEVA 120 MG/1.7 ML VIAL

    Pricing Unit: ML | Drug Type:

    NDC Crossover Matching brand name "XGEVA" or generic name "Denosumab"

    NDCBrand NameGeneric Name
    55513-730XGEVAdenosumab
    55513-710Proliadenosumab

    Trademark Results [XGEVA]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    XGEVA
    XGEVA
    78944422 3921172 Live/Registered
    Amgen Inc.
    2006-08-03

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