FDA.reportPublic FDA data

Topiramate

Product NDC
76420-278
11-digit product format
764200278
Labeler code
76420
Product ID
76420-278_e838b0d0-6869-8c20-e053-2a95a90a4d11
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Topiramate
Dosage form
TABLET
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA076343
Marketing category
ANDA
Marketing start
2014-06-12
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
76420-278-30Topiramate30 in 1 BOTTLETABLET301
76420-278-60Topiramate60 in 1 BOTTLETABLET601
76420-278-90Topiramate90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-278-30EA - Each76420-278021ed007-cd3f-4b9a-9b78-b45087d473a712022-10-06
76420-278-60EA - Each76420-2787771c544-603d-4c1c-b52d-348f6c69998c12022-10-06
76420-278-90EA - Each76420-278f4f318f9-a76b-407c-af27-3294f2d095d112022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-278TOPIRAMATE TABLET [ASCLEMED USA, INC.]1Current NDC, Legacy NDC, 3 package rows20220911_4e476c33-3590-4c6f-981d-915623cdacf0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199889topiramate 100 MG Oral TabletPSN4e476c33-3590-4c6f-981d-915623cdacf01
199890topiramate 200 MG Oral TabletPSN4e476c33-3590-4c6f-981d-915623cdacf01
199888topiramate 25 MG Oral TabletPSN4e476c33-3590-4c6f-981d-915623cdacf01
151226topiramate 50 MG Oral TabletPSN4e476c33-3590-4c6f-981d-915623cdacf01
199889topiramate 100 MG Oral TabletSCD4e476c33-3590-4c6f-981d-915623cdacf01
199890topiramate 200 MG Oral TabletSCD4e476c33-3590-4c6f-981d-915623cdacf01
199888topiramate 25 MG Oral TabletSCD4e476c33-3590-4c6f-981d-915623cdacf01
151226topiramate 50 MG Oral TabletSCD4e476c33-3590-4c6f-981d-915623cdacf01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76420-278-307642002783030 TABLET in 1 BOTTLE (76420-278-30) 30 tablet2022-09-090000-00-00NoNoCurrent
76420-278-607642002786060 TABLET in 1 BOTTLE (76420-278-60) 60 tablet2022-09-090000-00-00NoNoCurrent
76420-278-907642002789090 TABLET in 1 BOTTLE (76420-278-90) 90 tablet2022-09-090000-00-00NoNoCurrent