Topiramate

Product NDC

55700-210

11-digit product format

557000210

Labeler code

55700

Product ID

55700-210_850e0fd9-fb44-4795-a75c-7bad155ab1a9

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Topiramate

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Lake Erie Medical DBA Quality Care Products LLC

Application

ANDA078235

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

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record