NDC 57665-002

Revcovi

Elapegademase-lvlr

Revcovi is a Intramuscular Injection in the Human Prescription Drug category. It is labeled and distributed by Leadiant Biosciences, Inc.. The primary component is Elapegademase.

• Product ID: 57665-002_08d0d6b3-74f7-43e3-a921-49d9a7ee8bb6
• NDC: 57665-002
• Product Type: Human Prescription Drug
• Proprietary Name: Revcovi
• Generic Name: Elapegademase-lvlr
• Dosage Form: Injection
• Route of Administration: INTRAMUSCULAR
• Marketing Start Date: 2018-10-05
• Marketing Category: BLA / BLA
• Application Number: BLA761092
• Labeler Name: Leadiant Biosciences, Inc.
• Substance Name: ELAPEGADEMASE
• Active Ingredient Strength: 2 mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 57665-002-01

1 VIAL in 1 CARTON (57665-002-01) > 1.5 mL in 1 VIAL

• Marketing Start Date: 2018-10-05
• Marketing End Date: 2022-08-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 57665-002-01 [57665000201]

Revcovi INJECTION

• Marketing Category: BLA
• Application Number: BLA761092
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-10-05

Drug Details

Active Ingredients

Ingredient	Strength
ELAPEGADEMASE	1.6 mg/mL

OpenFDA Data

• SPL SET ID: af433fd8-b1cd-4c11-85a7-bfee7d6bba9e
• Manufacturer:
  • Leadiant Biosciences, Inc.
• UNII:
  • 9R3D3Y0UHS
• RxNorm Concept Unique ID - RxCUI:
  • 2059223
  • 2059228

NDC Crossover Matching brand name "Revcovi" or generic name "Elapegademase-lvlr"

NDC	Brand Name	Generic Name
10122-502	Revcovi	elapegademase-lvlr
57665-002	Revcovi	elapegademase-lvlr