NDC 72511-750

REPATHA

Evolocumab

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

• Product ID: 72511-750_5c290345-517d-4a4f-8a6c-7b84f07e7033
• NDC: 72511-750
• Product Type: Human Prescription Drug
• Proprietary Name: REPATHA
• Generic Name: Evolocumab
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2018-10-09
• Marketing Category: BLA / BLA
• Application Number: BLA125522
• Labeler Name: Amgen USA Inc.
• Substance Name: EVOLOCUMAB
• Active Ingredient Strength: 140 mg/mL
• Pharm Classes: Antibodies, Monoclonal [CS], PCSK9 Inhibitor [EPC], PCSK9 Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 72511-750-01

1 SYRINGE in 1 CARTON (72511-750-01) > 1 mL in 1 SYRINGE

• Marketing Start Date: 2018-10-09
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 72511-750-01 [72511075001]

REPATHA INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125522
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-10-09

Drug Details

Active Ingredients

Ingredient	Strength
EVOLOCUMAB	140 mg/mL

OpenFDA Data

• SPL SET ID: cd61e902-166d-4aa6-9f3c-a18c1008d07e
• Manufacturer:
  • Amgen USA Inc.
• UNII:
  • LKC0U3A8NJ
• RxNorm Concept Unique ID - RxCUI:
  • 1665895
  • 1801322
  • 1801319
  • 1665904
  • 1665906
  • 1665900

Pharmacological Class

• PCSK9 Inhibitor [EPC]
• PCSK9 Inhibitors [MoA]
• Antibodies
• Monoclonal [CS]

NDC Crossover Matching brand name "REPATHA" or generic name "Evolocumab"

NDC	Brand Name	Generic Name
55513-750	REPATHA	Evolocumab
55513-760	REPATHA	Evolocumab
55513-770	REPATHA	Evolocumab
72511-750	REPATHA	Evolocumab
72511-760	REPATHA	Evolocumab
72511-770	REPATHA	REPATHA