NDC 55513-760

REPATHA

Evolocumab

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

• Product ID: 55513-760_02a067d5-ee1b-4d79-aea5-d0e843246a64
• NDC: 55513-760
• Product Type: Human Prescription Drug
• Proprietary Name: REPATHA
• Generic Name: Evolocumab
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2015-08-31
• Marketing Category: BLA / BLA
• Application Number: BLA125522
• Labeler Name: Amgen Inc
• Substance Name: EVOLOCUMAB
• Active Ingredient Strength: 140 mg/mL
• Pharm Classes: PCSK9 Inhibitor [EPC],PCSK9 Inhibitors [MoA],Antibodies, Monoclonal [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 55513-760-01

1 SYRINGE in 1 CARTON (55513-760-01) > 1 mL in 1 SYRINGE

• Marketing Start Date: 2015-08-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55513-760-03 [55513076003]

REPATHA INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125522
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-08-31

NDC 55513-760-02 [55513076002]

REPATHA INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125522
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-08-31

NDC 55513-760-01 [55513076001]

REPATHA INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125522
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-08-31

Drug Details

Active Ingredients

Ingredient	Strength
EVOLOCUMAB	140 mg/mL

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

Pharmacological Class

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

Medicade Reported Pricing

55513076002 REPATHA 140 MG/ML SURECLICK

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