NDC 66658-505

GAMIFANT

(emapalumab-lzsg)

GAMIFANT is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Swedish Orphan Biovitrum Ab (publ). The primary component is Emapalumab.

• Product ID: 66658-505_41ca7358-b40f-4721-a585-d9466faf8aa9
• NDC: 66658-505
• Product Type: Human Prescription Drug
• Proprietary Name: GAMIFANT
• Generic Name: (emapalumab-lzsg)
• Dosage Form: Injection
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2019-05-17
• Marketing Category: BLA / BLA
• Application Number: BLA761107
• Labeler Name: Swedish Orphan Biovitrum AB (publ)
• Substance Name: EMAPALUMAB
• Active Ingredient Strength: 50 mg/10mL
• Pharm Classes: Interferon gamma Blocker [EPC],Interferon gamma Antagonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 66658-505-01

1 VIAL, SINGLE-USE in 1 CARTON (66658-505-01) > 10 mL in 1 VIAL, SINGLE-USE

• Marketing Start Date: 2019-05-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 66658-505-01 [66658050501]

GAMIFANT INJECTION

• Marketing Category: BLA
• Application Number: BLA761107
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-05-17

Drug Details

Active Ingredients

Ingredient	Strength
EMAPALUMAB	50 mg/10mL

OpenFDA Data

• SPL SET ID: a865e0ef-8685-4f69-8838-648c4f3bab47
• Manufacturer:
  • Swedish Orphan Biovitrum AB (publ)
• UNII:
  • 3S252O2Z4X

Pharmacological Class

• Interferon gamma Blocker [EPC]
• Interferon gamma Antagonists [MoA]

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)