Topiramate

Product NDC
50090-3752
11-digit product format
500903752
Labeler code
50090
Product ID
50090-3752_bfe18ed1-fe1f-45b8-b517-16d8ba4ed346
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Topiramate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090278
Marketing category
ANDA
Marketing start
2014-12-15
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
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3752-0EA - Each50090-3752a7b1ddd1-1315-4e37-b2c6-51c66a06038112021-11-09
50090-3752-2EA - Each50090-375279609f20-cee5-41c8-a402-61b729f1d15912021-08-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3752-05009037520060 TABLET, FILM COATED in 1 BOTTLE (50090-3752-0) 2018-10-310000-00-00NoNoCurrent
50090-3752-15009037520130 TABLET, FILM COATED in 1 BOTTLE (50090-3752-1) 2018-10-310000-00-00NoNoCurrent
50090-3752-25009037520290 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3752-2) 2014-12-150000-00-00NoNoCurrent