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
49b08648-6a83-42c7-ae7b-80c29f2534fc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 17, 2023
Manufacturers
FDA
Gland Pharma Limited
DUNS: 918601238
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 Code68083-460
Application NumberANDA214926
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fosphenytoin sodium
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateOctober 17, 2023
FDA Product Classification
INGREDIENTS (5)
FOSPHENYTOIN SODIUMActive
Quantity: 50 mg in 1 mL
Code: 7VLR55452Z
Classification: ACTIR
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TROMETHAMINEInactive
Code: 023C2WHX2V
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
Fosphenytoin sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68083-461
Application NumberANDA214926
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fosphenytoin sodium
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateOctober 17, 2023
FDA Product Classification
INGREDIENTS (5)
FOSPHENYTOIN SODIUMActive
Quantity: 50 mg in 1 mL
Code: 7VLR55452Z
Classification: ACTIR
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TROMETHAMINEInactive
Code: 023C2WHX2V
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT