Phenytoin

Product NDC

64950-231

11-digit product format

649500231

Labeler code

64950

Product ID

64950-231_2fb36740-2b6a-4d72-ba36-0317889b9ad3

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Phenytoin

Dosage form

SUSPENSION

Route

ORAL

Labeler

Genus Lifesciences Inc.

Application

ANDA040610

Marketing category

ANDA

Marketing start

2014-04-01

Marketing end

0000-00-00

Substance

PHENYTOIN

Active strength

125 mg/5mL

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

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record