FDA.reportPublic FDA data

Topiramate

Product NDC
63187-758
11-digit product format
631870758
Labeler code
63187
Product ID
63187-758_f4311c55-f736-4e0d-a743-0b6fdd1395b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Topiramate
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA076343
Marketing category
ANDA
Marketing start
2014-06-12
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
63187-758-30Topiramate30 in 1 BOTTLETABLET303
63187-758-60Topiramate60 in 1 BOTTLETABLET603
63187-758-90Topiramate90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-758-30EA - Each63187-758ada2ce13-3b86-4ed7-96fe-101a7948363312016-11-08
63187-758-60EA - Each63187-7588448ff90-02e6-4e6e-a9fe-fff87b9e495412021-03-02
63187-758-90EA - Each63187-7587c9fc441-7ead-465e-b90b-c9e53555359012017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-758TOPIRAMATE TABLET [PROFICIENT RX LP]3Current NDC, Legacy NDC, 3 package rows20220513_57ac12ed-27f0-4f5c-96ae-a7433714b429.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
151226topiramate 50 MG Oral TabletPSN57ac12ed-27f0-4f5c-96ae-a7433714b4293
151226topiramate 50 MG Oral TabletSCD57ac12ed-27f0-4f5c-96ae-a7433714b4293

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-758-306318707583030 TABLET in 1 BOTTLE (63187-758-30) 30 tablet2016-10-030000-00-00NoNoCurrent
63187-758-606318707586060 TABLET in 1 BOTTLE (63187-758-60) 60 tablet2016-10-030000-00-00NoNoCurrent
63187-758-906318707589090 TABLET in 1 BOTTLE (63187-758-90) 90 tablet2016-10-030000-00-00NoNoCurrent