Phenytoin Sodium
These highlights do not include all the information needed to use PHENYTOIN SODIUM INJECTION safely and effectively. See full prescribing information for PHENYTOIN SODIUM INJECTION. PHENYTOIN Sodium Injection f o r intravenous or intramuscular use Initial U.S. Approval: 1953
Approved
Approval ID
035a8d4e-2063-4240-83cb-d7eebcabe301
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 18, 2024
Manufacturers
FDA
Hikma Pharmaceuticals USA Inc.
DUNS: 946499746
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Phenytoin Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0641-2555
Application NumberANDA084307
Product Classification
M
Marketing Category
C73584
G
Generic Name
Phenytoin Sodium
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateJanuary 18, 2024
FDA Product Classification
INGREDIENTS (5)
PROPYLENE GLYCOLInactive
Quantity: 0.4 mL in 1 mL
Code: 6DC9Q167V3
Classification: IACT
ALCOHOLInactive
Quantity: 0.1 mL in 1 mL
Code: 3K9958V90M
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
PHENYTOIN SODIUMActive
Quantity: 50 mg in 1 mL
Code: 4182431BJH
Classification: ACTIB
Phenytoin Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0641-0493
Application NumberANDA084307
Product Classification
M
Marketing Category
C73584
G
Generic Name
Phenytoin Sodium
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateJanuary 18, 2024
FDA Product Classification
INGREDIENTS (5)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENYTOIN SODIUMActive
Quantity: 50 mg in 1 mL
Code: 4182431BJH
Classification: ACTIB
PROPYLENE GLYCOLInactive
Quantity: 0.4 mL in 1 mL
Code: 6DC9Q167V3
Classification: IACT
ALCOHOLInactive
Quantity: 0.1 mL in 1 mL
Code: 3K9958V90M
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT