FDA Product

Fosphenytoin Sodium

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

Fosphenytoin Sodium

FDA Product Code

65162-998

Regulatory Information

NDC Product Code

65162-998

Application Number

ANDA078476

Marketing Category

C73584

Effective Date

December 18, 2023

Territorial Authority

USA

FDA Title

Fosphenytoin Sodium Injection, USP Rx Only

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

15

Company Information

ManufacturerAmneal Pharmaceuticals LLC

DUNS Number

123797875

Active Ingredients

WATER

Code: 059QF0KO0R

Class Code: IACT

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

Active Moieties

PHENYTOIN

Code: 6158TKW0C5

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