FDA.reportPublic FDA data

topiramate

Product NDC
71335-1143
11-digit product format
713351143
Labeler code
71335
Product ID
71335-1143_78304e2a-31b5-4b0b-9f72-1842b7735bce
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-1143-12024-05-17C16284748780-11030e365-4d45-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use TOPIRAMATE safely and effectively. See full prescribing information for TOPIRAMATE. TOPIRAMATE tablets, for oral use TOPIRAMATE capsules, for oral use Initial U.S. Approval-1996
71335-1143-22024-05-17C16284748780-11030e365-4d45-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use TOPIRAMATE safely and effectively. See full prescribing information for TOPIRAMATE. TOPIRAMATE tablets, for oral use TOPIRAMATE capsules, for oral use Initial U.S. Approval-1996
71335-1143-32024-05-17C16284748780-11030e365-4d45-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use TOPIRAMATE safely and effectively. See full prescribing information for TOPIRAMATE. TOPIRAMATE tablets, for oral use TOPIRAMATE capsules, for oral use Initial U.S. Approval-1996
71335-1143-42024-05-17C16284748780-11030e365-4d45-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use TOPIRAMATE safely and effectively. See full prescribing information for TOPIRAMATE. TOPIRAMATE tablets, for oral use TOPIRAMATE capsules, for oral use Initial U.S. Approval-1996
71335-1143-52024-05-17C16284748780-11030e365-4d45-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use TOPIRAMATE safely and effectively. See full prescribing information for TOPIRAMATE. TOPIRAMATE tablets, for oral use TOPIRAMATE capsules, for oral use Initial U.S. Approval-1996
71335-1143-62024-05-17C16284748780-11030e365-4d45-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use TOPIRAMATE safely and effectively. See full prescribing information for TOPIRAMATE. TOPIRAMATE tablets, for oral use TOPIRAMATE capsules, for oral use Initial U.S. Approval-1996
71335-1143-72024-05-17C16284748780-11030e365-4d45-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use TOPIRAMATE safely and effectively. See full prescribing information for TOPIRAMATE. TOPIRAMATE tablets, for oral use TOPIRAMATE capsules, for oral use Initial U.S. Approval-1996
71335-1143-82024-05-17C16284748780-11030e365-4d45-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use TOPIRAMATE safely and effectively. See full prescribing information for TOPIRAMATE. TOPIRAMATE tablets, for oral use TOPIRAMATE capsules, for oral use Initial U.S. Approval-1996
71335-1143-12024-01-30C16284748780-11030e365-4d45-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use TOPIRAMATE safely and effectively. See full prescribing information for TOPIRAMATE. TOPIRAMATE tablets, for oral use TOPIRAMATE capsules, for oral use Initial U.S. Approval-1996
71335-1143-22024-01-30C16284748780-11030e365-4d45-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use TOPIRAMATE safely and effectively. See full prescribing information for TOPIRAMATE. TOPIRAMATE tablets, for oral use TOPIRAMATE capsules, for oral use Initial U.S. Approval-1996
71335-1143-32024-01-30C16284748780-11030e365-4d45-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use TOPIRAMATE safely and effectively. See full prescribing information for TOPIRAMATE. TOPIRAMATE tablets, for oral use TOPIRAMATE capsules, for oral use Initial U.S. Approval-1996
71335-1143-42024-01-30C16284748780-11030e365-4d45-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use TOPIRAMATE safely and effectively. See full prescribing information for TOPIRAMATE. TOPIRAMATE tablets, for oral use TOPIRAMATE capsules, for oral use Initial U.S. Approval-1996
71335-1143-52024-01-30C16284748780-11030e365-4d45-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use TOPIRAMATE safely and effectively. See full prescribing information for TOPIRAMATE. TOPIRAMATE tablets, for oral use TOPIRAMATE capsules, for oral use Initial U.S. Approval-1996
71335-1143-62024-01-30C16284748780-11030e365-4d45-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use TOPIRAMATE safely and effectively. See full prescribing information for TOPIRAMATE. TOPIRAMATE tablets, for oral use TOPIRAMATE capsules, for oral use Initial U.S. Approval-1996
71335-1143-72024-01-30C16284748780-11030e365-4d45-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use TOPIRAMATE safely and effectively. See full prescribing information for TOPIRAMATE. TOPIRAMATE tablets, for oral use TOPIRAMATE capsules, for oral use Initial U.S. Approval-1996
71335-1143-82024-01-30C16284748780-11030e365-4d45-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use TOPIRAMATE safely and effectively. See full prescribing information for TOPIRAMATE. TOPIRAMATE tablets, for oral use TOPIRAMATE capsules, for oral use Initial U.S. Approval-1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1143-1topiramate60 in 1 BOTTLETABLET, FILM COATED60102
71335-1143-2topiramate30 in 1 BOTTLETABLET, FILM COATED30102
71335-1143-3topiramate90 in 1 BOTTLETABLET, FILM COATED90102
71335-1143-4topiramate120 in 1 BOTTLETABLET, FILM COATED120102
71335-1143-5topiramate50 in 1 BOTTLETABLET, FILM COATED50102
71335-1143-6topiramate14 in 1 BOTTLETABLET, FILM COATED14102
71335-1143-7topiramate45 in 1 BOTTLETABLET, FILM COATED45102
71335-1143-8topiramate7 in 1 BOTTLETABLET, FILM COATED7102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1143-1EA - Each71335-1143674f1aa8-bbdc-421c-a145-20e47e7318c912019-10-07
71335-1143-2EA - Each71335-1143c9b23556-1cfb-40b9-8060-ebb268ddc59112019-10-07
71335-1143-3EA - Each71335-1143f743cbf7-51b0-4c01-83b8-26e91a540e9f12019-10-07
71335-1143-4EA - Each71335-114301b47567-9c04-4ec4-8ff6-9f5b87e4b9bf12019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1143TOPIRAMATE TABLET, FILM COATED [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 8 package rows20240518_bffcd213-4f09-4a5b-8ccb-591a68be402b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199889topiramate 100 MG Oral TabletPSNbffcd213-4f09-4a5b-8ccb-591a68be402b102
199889topiramate 100 MG Oral TabletSCDbffcd213-4f09-4a5b-8ccb-591a68be402b102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1143-17133511430160 TABLET, FILM COATED in 1 BOTTLE (71335-1143-1) 2019-04-250000-00-00NoNoCurrent
71335-1143-27133511430230 TABLET, FILM COATED in 1 BOTTLE (71335-1143-2) 2019-03-070000-00-00NoNoCurrent
71335-1143-37133511430390 TABLET, FILM COATED in 1 BOTTLE (71335-1143-3) 2019-04-160000-00-00NoNoCurrent
71335-1143-471335114304120 TABLET, FILM COATED in 1 BOTTLE (71335-1143-4) 2019-06-070000-00-00NoNoCurrent
71335-1143-57133511430550 TABLET, FILM COATED in 1 BOTTLE (71335-1143-5) 2024-05-170000-00-00NoNoCurrent
71335-1143-67133511430614 TABLET, FILM COATED in 1 BOTTLE (71335-1143-6) 2019-04-240000-00-00NoNoCurrent
71335-1143-77133511430745 TABLET, FILM COATED in 1 BOTTLE (71335-1143-7) 2024-05-170000-00-00NoNoCurrent
71335-1143-8713351143087 TABLET, FILM COATED in 1 BOTTLE (71335-1143-8) 2019-04-240000-00-00NoNoCurrent