Phenytoin

Product NDC

51079-129

11-digit product format

510790129

Labeler code

51079

Product ID

51079-129_7e0417d6-3470-7def-e053-2a91aa0a7d22

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Phenytoin

Dosage form

TABLET, CHEWABLE

Route

ORAL

Labeler

Mylan Institutional Inc.

Application

ANDA200691

Marketing category

ANDA

Marketing start

2012-12-18

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

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record