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 ID: 55513-730_201abd85-c4ed-424f-8e79-ca1c34368d06
• NDC: 55513-730
• Product Type: Human Prescription Drug
• Proprietary Name: XGEVA
• Generic Name: Denosumab
• Dosage Form: Injection
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2010-11-18
• Marketing Category: BLA / BLA
• Application Number: BLA125320
• Labeler Name: Amgen Inc
• Substance Name: DENOSUMAB
• Active Ingredient Strength: 120 mg/1.7mL
• Pharm Classes: RANK Ligand Inhibitor [EPC],RANK Ligand Blocking Activity [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

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 Date: 2010-11-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55513-730-01 [55513073001]

XGEVA INJECTION

• Marketing Category: BLA
• Application Number: BLA125320
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2010-11-18

Drug Details

Active Ingredients

Ingredient	Strength
DENOSUMAB	120 mg/1.7mL

OpenFDA Data

• SPL SET ID: 628f0998-1206-4001-aeee-18133aa9f3bf
• Manufacturer:
  • Amgen Inc
• UNII:
  • 4EQZ6YO2HI
• 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"

NDC	Brand Name	Generic Name
55513-730	XGEVA	denosumab
55513-710	Prolia	denosumab