TOPIRAMATE

Product NDC

43063-094

11-digit product format

430630094

Labeler code

43063

Product ID

43063-094_8d55b333-e779-2b49-e053-2995a90ae5ae

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

topiramate

Dosage form

TABLET

Route

ORAL

Labeler

PD-Rx Pharmaceuticals, Inc.

Application

ANDA079153

Marketing category

ANDA

Marketing start

2009-03-27

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

No

Listing certified through

2020-12-31

Current FDA listing

Historical FDA.report record