Fosphenytoin Sodium

Basic Information

Product Name

Fosphenytoin Sodium

FDA Product Code

0641-6136

Regulatory Information

NDC Product Code

0641-6136

Application Number

ANDA077989

Marketing Category

C73584

Effective Date

February 23, 2023

Territorial Authority

USA

FDA Title

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, USP, for intravenous or intramuscular use Initial U.S. Approval: 1996

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

FOSPHENYTOIN SODIUM

Quantity: 50 mg in 1 mL

Code: 7VLR55452Z

Class Code: ACTIR

TROMETHAMINE

Code: 023C2WHX2V

Class Code: IACT

HYDROCHLORIC ACID

Code: QTT17582CB

Class Code: IACT

SODIUM HYDROXIDE

Code: 55X04QC32I

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

Active Moieties

PHENYTOIN

Code: 6158TKW0C5

Basic Information

Regulatory Information

Company Information

Active Ingredients

TROMETHAMINE

HYDROCHLORIC ACID

SODIUM HYDROXIDE

WATER

Active Moieties

PHENYTOIN