NDC 55513-710

Prolia

Denosumab

Prolia 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: 55513-710_1dc757ce-c06c-4669-ad85-35181469b2ed
• NDC: 55513-710
• Product Type: Human Prescription Drug
• Proprietary Name: Prolia
• Generic Name: Denosumab
• Dosage Form: Injection
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2010-06-05
• Marketing Category: BLA / BLA
• Application Number: BLA125320
• Labeler Name: Amgen Inc
• Substance Name: DENOSUMAB
• Active Ingredient Strength: 60 mg/mL
• Pharm Classes: RANK Ligand Inhibitor [EPC],RANK Ligand Blocking Activity [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 55513-710-01

1 SYRINGE in 1 CARTON (55513-710-01) > 1 mL in 1 SYRINGE

• Marketing Start Date: 2010-06-05
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55513-710-01 [55513071001]

Prolia INJECTION

• Marketing Category: BLA
• Application Number: BLA125320
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2010-06-05

Drug Details

Active Ingredients

Ingredient	Strength
DENOSUMAB	60 mg/mL

OpenFDA Data

• SPL SET ID: 49e5afe9-a0c7-40c4-af9f-f287a80c5c88
• Manufacturer:
  • Amgen Inc
• UNII:
  • 4EQZ6YO2HI
• RxNorm Concept Unique ID - RxCUI:
  • 993452
  • 993456

Pharmacological Class

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

Medicade Reported Pricing

55513071001 PROLIA 60 MG/ML SYRINGE

Pricing Unit: ML | Drug Type:

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

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