FDA.reportPublic FDA data

Topiramate

Product NDC
63187-801
11-digit product format
631870801
Labeler code
63187
Product ID
63187-801_c2a2f49e-24ed-42dc-b52c-a473e8a39930
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Topiramate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA090278
Marketing category
ANDA
Marketing start
2014-12-15
Substance
TOPIRAMATE
Active strength
100 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
TOPIRAMATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0H73WJJ391
Rxcui199889

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
63187-801-30Topiramate30 in 1 BOTTLETABLET, FILM COATED303
63187-801-60Topiramate60 in 1 BOTTLETABLET, FILM COATED603
63187-801-90Topiramate90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-801-90EA - Each63187-801537a4744-489d-454d-92c6-61dfdbb598f512017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-801TOPIRAMATE TABLET, FILM COATED [PROFICIENT RX LP]3Current NDC, Legacy NDC, 3 package rows20191115_7d6752ce-7a56-4b04-ab15-cbd40aa5cc94.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199889topiramate 100 MG Oral TabletPSN7d6752ce-7a56-4b04-ab15-cbd40aa5cc943
199889topiramate 100 MG Oral TabletSCD7d6752ce-7a56-4b04-ab15-cbd40aa5cc943

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-801-306318708013030 TABLET, FILM COATED in 1 BOTTLE (63187-801-30) 2017-01-020000-00-00NoNoCurrent
63187-801-606318708016060 TABLET, FILM COATED in 1 BOTTLE (63187-801-60) 2017-01-020000-00-00NoNoCurrent
63187-801-906318708019090 TABLET, FILM COATED in 1 BOTTLE (63187-801-90) 2017-01-020000-00-00NoNoCurrent