Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Phenytoin Sodium
Product Details
NDC Product Code
0641-2555Application Number
ANDA084307Marketing Category
ANDA (C73584)Route of Administration
INTRAMUSCULAR, INTRAVENOUSEffective Date
January 18, 2024PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACTQuantity: 0.4 mL in 1 mL
ALCOHOLInactive
Code: 3K9958V90MClass: IACTQuantity: 0.1 mL in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
PhenytoinActive
Code: 4182431BJHClass: ACTIBQuantity: 50 mg in 1 mL
Phenytoin Sodium
Product Details
NDC Product Code
0641-0493Application Number
ANDA084307Marketing Category
ANDA (C73584)Route of Administration
INTRAMUSCULAR, INTRAVENOUSEffective Date
January 18, 2024WATERInactive
Code: 059QF0KO0RClass: IACT
PhenytoinActive
Code: 4182431BJHClass: ACTIBQuantity: 50 mg in 1 mL
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACTQuantity: 0.4 mL in 1 mL
ALCOHOLInactive
Code: 3K9958V90MClass: IACTQuantity: 0.1 mL in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT