Topiramate

Product NDC

63629-3995

11-digit product format

636293995

Labeler code

63629

Product ID

63629-3995_6039fd1b-5061-4071-aba3-2da49374f26c

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

topiramate

Dosage form

TABLET

Route

ORAL

Labeler

Bryant Ranch Prepack

Application

ANDA079162

Marketing category

ANDA

Marketing start

2009-03-27

Marketing end

0000-00-00

Substance

TOPIRAMATE

Active strength

50 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