Fosphenytoin Sodium
These highlights do not include all the information needed to use FOSPHENYTOIN SODIUM INJECTION, USP safely and effectively. See full prescribing information for FOSPHENYTOIN SODIUM INJECTION, USP. FOSPHENYTOIN SODIUM INJECTION, USP for intravenous or intramuscular use Initial U.S. Approval: 1996
Approved
Approval ID
c92df63b-5140-4213-8d43-8327ff6230b7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 4, 2018
Manufacturers
FDA
West-Ward Pharmaceuticals Corp
DUNS: 001230762
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fosphenytoin Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0143-9788
Application NumberANDA078765
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fosphenytoin Sodium
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateJanuary 5, 2018
FDA Product Classification
INGREDIENTS (5)
FOSPHENYTOIN SODIUMActive
Quantity: 50 mg in 1 mL
Code: 7VLR55452Z
Classification: ACTIR
TROMETHAMINEInactive
Quantity: 12 mg in 1 mL
Code: 023C2WHX2V
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
Fosphenytoin Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0143-9782
Application NumberANDA078765
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fosphenytoin Sodium
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateJanuary 5, 2018
FDA Product Classification
INGREDIENTS (5)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
FOSPHENYTOIN SODIUMActive
Quantity: 50 mg in 1 mL
Code: 7VLR55452Z
Classification: ACTIR
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
TROMETHAMINEInactive
Quantity: 12 mg in 1 mL
Code: 023C2WHX2V
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT