NDC 55513-770

REPATHA

Evolocumab

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

• Product ID: 55513-770_02a067d5-ee1b-4d79-aea5-d0e843246a64
• NDC: 55513-770
• Product Type: Human Prescription Drug
• Proprietary Name: REPATHA
• Generic Name: Evolocumab
• Dosage Form: Kit
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2016-08-01
• Marketing Category: BLA / BLA
• Application Number: BLA125522
• Labeler Name: Amgen Inc
• Active Ingredient Strength: 0
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 55513-770-01

1 KIT in 1 CARTON (55513-770-01) * 1 CARTRIDGE in 1 TRAY > 3.5 mL in 1 CARTRIDGE

• Marketing Start Date: 2016-08-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55513-770-01 [55513077001]

REPATHA KIT

• Marketing Category: BLA
• Application Number: BLA125522
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2016-08-01

Drug Details

OpenFDA Data

• SPL SET ID: 709338ae-ab8f-44a9-b7d5-abaabec3493a
• Manufacturer:
  • Amgen Inc
• UNII:
  • LKC0U3A8NJ
• RxNorm Concept Unique ID - RxCUI:
  • 1665895
  • 1801322
  • 1801319
  • 1665904
  • 1665906
  • 1665900

Medicade Reported Pricing

55513077001 REPATHA 420 MG/3.5 ML PUSHTRONX

Pricing Unit: ML | Drug Type:

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