Phenytoin Sodium

Product NDC

63629-2552

11-digit product format

636292552

Labeler code

63629

Product ID

63629-2552_958a3e12-0f99-4989-9f85-4aa0f3ebb086

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

phenytoin sodium

Dosage form

CAPSULE, EXTENDED RELEASE

Route

ORAL

Labeler

Bryant Ranch Prepack

Application

ANDA040298

Marketing category

ANDA

Marketing start

2011-07-07

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

2017-12-31

Current FDA listing

Historical FDA.report record