Fosphenytoin Sodium
These highlights do not include all the information needed to use FOSPHENYTOIN SODIUM INJECTION safely and effectively. See full prescribing information for FOSPHENYTOIN SODIUM INJECTION. FOSPHENYTOIN SODIUM injection, for intravenous or intramuscular use Initial U.S. Approval: 1996
Approved
Approval ID
39b58213-b9e2-4847-9010-99e187c1b778
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 25, 2022
Manufacturers
FDA
Amneal Pharmaceuticals LLC
DUNS: 827748190
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fosphenytoin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70121-1381
Application NumberANDA078476
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fosphenytoin
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateJuly 25, 2022
FDA Product Classification
INGREDIENTS (5)
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
FOSPHENYTOIN SODIUMActive
Quantity: 50 mg in 1 mL
Code: 7VLR55452Z
Classification: ACTIR
TROMETHAMINEInactive
Code: 023C2WHX2V
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
Fosphenytoin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70121-1390
Application NumberANDA078476
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fosphenytoin
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateJuly 25, 2022
FDA Product Classification
INGREDIENTS (5)
TROMETHAMINEInactive
Code: 023C2WHX2V
Classification: IACT
FOSPHENYTOIN SODIUMActive
Quantity: 50 mg in 1 mL
Code: 7VLR55452Z
Classification: ACTIR
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT