FDA.reportPublic FDA data

Topiramate

Product NDC
76282-278
11-digit product format
762820278
Labeler code
76282
Product ID
76282-278_9c981813-533d-40b5-b9ea-5648dd7c7da0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Topiramate
Dosage form
TABLET
Route
ORAL
Labeler
EXELAN PHARMACEUTICALS INC.
Application
ANDA079162
Marketing category
ANDA
Marketing start
2020-09-07
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Topiramate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOPIRAMATE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0H73WJJ391
Rxcui151226, 199888, 199889, 199890

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e5b1b0ba-27f8-4d5d-8943-8aed080fdedcProduct name420260306
6c26dd6d-01b5-4a80-b096-b3a6f7ca6077Product name220250623
cb966f54-bbf0-40fb-b581-80c6648d510cProduct name420250623
6e2fb0d7-40d7-e97c-1375-fa022ff20193Product name420250305
3d272a3f-17c0-421d-bc43-3cbdb719258dProduct name120250303

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76282-278-10Topiramate1000 in 1 BOTTLETABLET10003
76282-278-60Topiramate60 in 1 BOTTLETABLET603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76282-278TOPIRAMATE TABLET [EXELAN PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 2 package rows20250519_690baf58-1ec9-463e-99b7-d601362ea56b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199889topiramate 100 MG Oral TabletPSN690baf58-1ec9-463e-99b7-d601362ea56b3
199890topiramate 200 MG Oral TabletPSN690baf58-1ec9-463e-99b7-d601362ea56b3
199888topiramate 25 MG Oral TabletPSN690baf58-1ec9-463e-99b7-d601362ea56b3
151226topiramate 50 MG Oral TabletPSN690baf58-1ec9-463e-99b7-d601362ea56b3
199889topiramate 100 MG Oral TabletSCD690baf58-1ec9-463e-99b7-d601362ea56b3
199890topiramate 200 MG Oral TabletSCD690baf58-1ec9-463e-99b7-d601362ea56b3
199888topiramate 25 MG Oral TabletSCD690baf58-1ec9-463e-99b7-d601362ea56b3
151226topiramate 50 MG Oral TabletSCD690baf58-1ec9-463e-99b7-d601362ea56b3
199889topiramate 100 MG Oral TabletPSN3b18b43c-0de2-4acf-b0d5-f1b601d496de2
199890topiramate 200 MG Oral TabletPSN3b18b43c-0de2-4acf-b0d5-f1b601d496de2
199888topiramate 25 MG Oral TabletPSN3b18b43c-0de2-4acf-b0d5-f1b601d496de2
151226topiramate 50 MG Oral TabletPSN3b18b43c-0de2-4acf-b0d5-f1b601d496de2
199889topiramate 100 MG Oral TabletSCD3b18b43c-0de2-4acf-b0d5-f1b601d496de2
199890topiramate 200 MG Oral TabletSCD3b18b43c-0de2-4acf-b0d5-f1b601d496de2
199888topiramate 25 MG Oral TabletSCD3b18b43c-0de2-4acf-b0d5-f1b601d496de2
151226topiramate 50 MG Oral TabletSCD3b18b43c-0de2-4acf-b0d5-f1b601d496de2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76282-278-10762820278101000 TABLET in 1 BOTTLE (76282-278-10) 1000 tablet2020-09-070000-00-00NoNoCurrent
76282-278-607628202786060 TABLET in 1 BOTTLE (76282-278-60) 60 tablet2020-09-070000-00-00NoNoCurrent