Topamax

Product NDC
70518-2753
11-digit product format
705182753
Labeler code
70518
Product ID
70518-2753_dca34fa4-e59a-3f2a-e053-2a95a90a1651
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
topiramate
Dosage form
TABLET, COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
NDA020505
Marketing category
NDA
Marketing start
2020-05-26
Marketing end
0000-00-00
Substance
TOPIRAMATE
Active strength
25 mg/1
Pharmacologic classes
Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2753-07051827530030 TABLET, COATED in 1 BLISTER PACK (70518-2753-0) 2020-05-260000-00-00NoNoCurrent