Topiramate

Product NDC

0615-7565

11-digit product format

006157565

Labeler code

0615

Product ID

0615-7565_d8d1e518-2b20-4a4b-bd1d-f13c9f762d7a

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Topiramate

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

NCS HealthCare of KY, Inc dba Vangard Labs

Application

ANDA078235

Marketing category

ANDA

Marketing start

2009-03-27

Marketing end

0000-00-00

Substance

TOPIRAMATE

Active strength

200 mg/1

Pharmacologic classes

Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]

NDC exclude flag

E

Listing certified through

2017-12-31

Current FDA listing

Historical FDA.report record