NDC 55513-880

Evenity

Romosozumab-aqqg

Evenity is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Amgen Inc. The primary component is Romosozumab.

• Product ID: 55513-880_5636619f-733e-4e3b-b497-cd8e8b63999b
• NDC: 55513-880
• Product Type: Human Prescription Drug
• Proprietary Name: Evenity
• Generic Name: Romosozumab-aqqg
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2019-04-09
• Marketing Category: BLA / BLA
• Application Number: BLA761062
• Labeler Name: Amgen Inc
• Substance Name: ROMOSOZUMAB
• Active Ingredient Strength: 105 mg/1.17mL
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 55513-880-02

2 SYRINGE in 1 CARTON (55513-880-02) > 1.17 mL in 1 SYRINGE (55513-880-01)

• Marketing Start Date: 2019-04-09
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55513-880-01 [55513088001]

Evenity INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA761062
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-04-09

NDC 55513-880-02 [55513088002]

Evenity INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA761062
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-04-09

Drug Details

Active Ingredients

Ingredient	Strength
ROMOSOZUMAB	105 mg/1.17mL

OpenFDA Data

• SPL SET ID: 471baba2-7154-4488-9891-0db2f46791e7
• Manufacturer:
  • Amgen Inc
• UNII:
  • 3VHF2ZD92J
• UPC Code:
  • 0355513880022