FDA.reportPublic FDA data

Topiramate

Product NDC
63187-228
11-digit product format
631870228
Labeler code
63187
Product ID
63187-228_2fc556b9-f5e3-412e-a250-72dd83490ad6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Topiramate
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA079162
Marketing category
ANDA
Marketing start
2011-01-01
Substance
TOPIRAMATE
Active strength
50 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
TOPIRAMATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0H73WJJ391
Rxcui151226

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
63187-228-30Topiramate30 in 1 BOTTLETABLET304
63187-228-60Topiramate60 in 1 BOTTLETABLET604
63187-228-90Topiramate90 in 1 BOTTLETABLET904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-228TOPIRAMATE TABLET [PROFICIENT RX LP]4Current NDC, Legacy NDC, 3 package rows20210121_e9c4e279-0ef9-4e96-8741-dfe7556953d9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
151226topiramate 50 MG Oral TabletPSNe9c4e279-0ef9-4e96-8741-dfe7556953d94
151226topiramate 50 MG Oral TabletSCDe9c4e279-0ef9-4e96-8741-dfe7556953d94

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-228-306318702283030 TABLET in 1 BOTTLE (63187-228-30) 30 tablet2019-01-010000-00-00NoNoCurrent
63187-228-606318702286060 TABLET in 1 BOTTLE (63187-228-60) 60 tablet2019-04-010000-00-00NoNoCurrent
63187-228-906318702289090 TABLET in 1 BOTTLE (63187-228-90) 90 tablet2019-01-010000-00-00NoNoCurrent