Phenytoin Sodium

Product NDC

0615-1343

11-digit product format

006151343

Labeler code

0615

Product ID

0615-1343_963929bb-80d0-4b86-a6e1-555f6985af57

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

phenytoin sodium

Dosage form

CAPSULE, EXTENDED RELEASE

Route

ORAL

Labeler

NCS HealthCare of KY, Inc dba Vangard Labs

Application

ANDA040298

Marketing category

ANDA

Marketing start

2009-11-20

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