Phenytoin

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Labeler

American Health Packaging

DUNS Number

929561009

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

60687-275

Application Number

ANDA040521

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

October 31, 2022

Ingredients

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

MAGNESIUM ALUMINUM SILICATEInactive

Code: 6M3P64V0NCClass: IACT

CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMInactive

Code: K679OBS311Class: IACT

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSLClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

POLYSORBATE 60Inactive

Code: CAL22UVI4MClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

Code: 6158TKW0C5Class: ACTIBQuantity: 125 mg in 5 mL

SODIUM BENZOATEInactive

Code: OJ245FE5EUClass: IACT