NDC 72171-501

GAMIFANT

(emapalumab-lzsg)

GAMIFANT is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Novimmune Sa. The primary component is Emapalumab.

• Product ID: 72171-501_3b952566-94f7-494a-ba9c-044799721b93
• NDC: 72171-501
• Product Type: Human Prescription Drug
• Proprietary Name: GAMIFANT
• Generic Name: (emapalumab-lzsg)
• Dosage Form: Injection
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2018-11-20
• Marketing Category: BLA / BLA
• Application Number: BLA761107
• Labeler Name: NovImmune SA
• Substance Name: EMAPALUMAB
• Active Ingredient Strength: 10 mg/2mL
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 72171-501-01

1 VIAL, SINGLE-USE in 1 CARTON (72171-501-01) > 2 mL in 1 VIAL, SINGLE-USE

• Marketing Start Date: 2018-11-20
• Marketing End Date: 2021-11-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 72171-501-01 [72171050101]

GAMIFANT INJECTION

• Marketing Category: BLA
• Application Number: BLA761107
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-11-20
• Marketing End Date: 2021-11-30

Drug Details

Active Ingredients

Ingredient	Strength
EMAPALUMAB	10 mg/2mL

OpenFDA Data

• SPL SET ID: 203459a5-9769-44a0-8396-43d110207ba9
• Manufacturer:
  • NovImmune SA
• UNII:
  • 3S252O2Z4X
• RxNorm Concept Unique ID - RxCUI:
  • 2104622
  • 2104611
  • 2104621
  • 2104616

NDC Crossover Matching brand name "GAMIFANT" or generic name "(emapalumab-lzsg)"

NDC	Brand Name	Generic Name
66658-501	GAMIFANT	(emapalumab-lzsg)
66658-505	GAMIFANT	(emapalumab-lzsg)
66658-510	GAMIFANT	(emapalumab-lzsg)
72171-501	GAMIFANT	(emapalumab-lzsg)
72171-505	GAMIFANT	(emapalumab-lzsg)