Extended Phenytoin Sodium

Product NDC

68788-6968

11-digit product format

687886968

Labeler code

68788

Product ID

68788-6968_9f1afadf-c58e-48d9-a013-e78c792f078d

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Phenytoin Sodium

Dosage form

CAPSULE

Route

ORAL

Labeler

Preferred Pharmaceuticals Inc.

Application

ANDA204309

Marketing category

ANDA

Marketing start

2017-05-18

Marketing end

0000-00-00

Substance

PHENYTOIN SODIUM

Active strength

100 mg/1

Pharmacologic classes

Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA]

NDC exclude flag

E

Listing certified through

2018-12-31

Current FDA listing

Historical FDA.report record