Phenytoin

Product NDC

0615-7764

11-digit product format

006157764

Labeler code

0615

Product ID

0615-7764_72ca248c-2b35-4319-b081-855f3ce1b5d3

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Phenytoin

Dosage form

TABLET, CHEWABLE

Route

ORAL

Labeler

NCS HealthCare of KY, Inc dba Vangard Labs

Application

ANDA200691

Marketing category

ANDA

Marketing start

2012-12-26

Marketing end

0000-00-00

Substance

PHENYTOIN

Active strength

50 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

2017-12-31

Current FDA listing

Historical FDA.report record