FDA.reportPublic FDA data

topiramate

Product NDC
71335-1147
11-digit product format
713351147
Labeler code
71335
Product ID
71335-1147_eb66045e-43b6-46c2-ac9d-c7ccc7f938b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
topiramate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078235
Marketing category
ANDA
Marketing start
2009-03-27
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
71335-1147-0topiramate20 in 1 BOTTLETABLET, FILM COATED20103
71335-1147-1topiramate30 in 1 BOTTLETABLET, FILM COATED30103
71335-1147-2topiramate60 in 1 BOTTLETABLET, FILM COATED60103
71335-1147-3topiramate90 in 1 BOTTLETABLET, FILM COATED90103
71335-1147-4topiramate120 in 1 BOTTLETABLET, FILM COATED120103
71335-1147-5topiramate7 in 1 BOTTLETABLET, FILM COATED7103
71335-1147-6topiramate80 in 1 BOTTLETABLET, FILM COATED80103
71335-1147-7topiramate14 in 1 BOTTLETABLET, FILM COATED14103
71335-1147-8topiramate45 in 1 BOTTLETABLET, FILM COATED45103
71335-1147-9topiramate28 in 1 BOTTLETABLET, FILM COATED28103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1147-1EA - Each71335-1147820b04b9-4e28-467c-af54-b629deb246cc12019-10-07
71335-1147-2EA - Each71335-1147798cbb73-ea96-4169-ae64-5ff15ffa594312019-10-07
71335-1147-3EA - Each71335-1147fdff6d71-9a52-475a-92de-4d29c12a682812019-10-07
71335-1147-5EA - Each71335-11470defe487-1192-449a-9352-ebf414659ba012019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1147TOPIRAMATE TABLET, FILM COATED [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 10 package rows20240526_ca9ce6c1-5a60-467a-9ad5-acc7a9f8ca15.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
151226topiramate 50 MG Oral TabletPSNca9ce6c1-5a60-467a-9ad5-acc7a9f8ca15103
151226topiramate 50 MG Oral TabletSCDca9ce6c1-5a60-467a-9ad5-acc7a9f8ca15103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1147-07133511470020 TABLET, FILM COATED in 1 BOTTLE (71335-1147-0) 2022-05-020000-00-00NoNoCurrent
71335-1147-17133511470130 TABLET, FILM COATED in 1 BOTTLE (71335-1147-1) 2019-03-290000-00-00NoNoCurrent
71335-1147-27133511470260 TABLET, FILM COATED in 1 BOTTLE (71335-1147-2) 2019-03-040000-00-00NoNoCurrent
71335-1147-37133511470390 TABLET, FILM COATED in 1 BOTTLE (71335-1147-3) 2019-03-140000-00-00NoNoCurrent
71335-1147-471335114704120 TABLET, FILM COATED in 1 BOTTLE (71335-1147-4) 2020-02-040000-00-00NoNoCurrent
71335-1147-5713351147057 TABLET, FILM COATED in 1 BOTTLE (71335-1147-5) 2020-08-030000-00-00NoNoCurrent
71335-1147-67133511470680 TABLET, FILM COATED in 1 BOTTLE (71335-1147-6) 2022-05-020000-00-00NoNoCurrent
71335-1147-77133511470714 TABLET, FILM COATED in 1 BOTTLE (71335-1147-7) 2020-11-020000-00-00NoNoCurrent
71335-1147-87133511470845 TABLET, FILM COATED in 1 BOTTLE (71335-1147-8) 2022-05-020000-00-00NoNoCurrent
71335-1147-97133511470928 TABLET, FILM COATED in 1 BOTTLE (71335-1147-9) 2020-08-140000-00-00NoNoCurrent