Topamax

Product NDC
70518-1393
11-digit product format
705181393
Labeler code
70518
Product ID
70518-1393_92ba5957-e541-1a75-e053-2a95a90ad475
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
topiramate
Dosage form
TABLET, COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
NDA020505
Marketing category
NDA
Marketing start
2018-08-29
Marketing end
0000-00-00
Substance
TOPIRAMATE
Active strength
100 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