topiramate

Product NDC

54569-6137

11-digit product format

545696137

Labeler code

54569

Product ID

54569-6137_7bb8333d-1eb8-49dc-816c-20caf9d2acfb

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

topiramate

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

A-S Medication Solutions

Application

ANDA090162

Marketing category

ANDA

Marketing start

2013-07-01

Marketing end

0000-00-00

Substance

TOPIRAMATE

Active strength

25 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