Topiramate

Product NDC
55700-596
11-digit product format
557000596
Labeler code
55700
Product ID
55700-596_0f71fae0-6f40-44ea-b272-1e060f410f37
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Topiramate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA090278
Marketing category
ANDA
Marketing start
2014-12-15
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
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55700-596-2755700059627270 TABLET, FILM COATED in 1 BOTTLE (55700-596-27) 2018-04-070000-00-00NoNoCurrent
55700-596-305570005963030 TABLET, FILM COATED in 1 BOTTLE (55700-596-30) 2018-04-070000-00-00NoNoCurrent
55700-596-605570005966060 TABLET, FILM COATED in 1 BOTTLE (55700-596-60) 2018-04-070000-00-00NoNoCurrent
55700-596-905570005969090 TABLET, FILM COATED in 1 BOTTLE (55700-596-90) 2018-04-070000-00-00NoNoCurrent