FDA.reportPublic FDA data

Topiramate

Product NDC
68071-1971
11-digit product format
680711971
Labeler code
68071
Product ID
68071-1971_3ab5a044-1530-14af-e063-6394a90a35ca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Topiramate
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA076343
Marketing category
ANDA
Marketing start
2014-06-12
Substance
TOPIRAMATE
Active strength
25 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
TOPIRAMATE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0H73WJJ391
Rxcui199888

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
68071-1971-32024-07-16C16284748780-1ba0f9c33-4e26-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use TOPIRAMATE tablets, USP safely and effectively. See full prescribing information for TOPIRAMATE tablets, USP. TOPIRAMATE tablets USP, for oral Use. Initial U.S. Approval: 1996
68071-1971-62024-07-16C16284748780-1ba0f9c33-4e26-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use TOPIRAMATE tablets, USP safely and effectively. See full prescribing information for TOPIRAMATE tablets, USP. TOPIRAMATE tablets USP, for oral Use. Initial U.S. Approval: 1996
68071-1971-92024-07-16C16284748780-1ba0f9c33-4e26-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use TOPIRAMATE tablets, USP safely and effectively. See full prescribing information for TOPIRAMATE tablets, USP. TOPIRAMATE tablets USP, for oral Use. Initial U.S. Approval: 1996
68071-1971-32023-01-30C16284748780-1ba0f9c33-4e26-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use TOPIRAMATE tablets, USP safely and effectively. See full prescribing information for TOPIRAMATE tablets, USP. TOPIRAMATE tablets USP, for oral Use. Initial U.S. Approval: 1996
68071-1971-62023-01-30C16284748780-1ba0f9c33-4e26-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use TOPIRAMATE tablets, USP safely and effectively. See full prescribing information for TOPIRAMATE tablets, USP. TOPIRAMATE tablets USP, for oral Use. Initial U.S. Approval: 1996
68071-1971-92023-01-30C16284748780-1ba0f9c33-4e26-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use TOPIRAMATE tablets, USP safely and effectively. See full prescribing information for TOPIRAMATE tablets, USP. TOPIRAMATE tablets USP, for oral Use. Initial U.S. Approval: 1996
68071-1971-32021-02-23C16284748780-1ba0f9c33-4e26-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use TOPIRAMATE tablets, USP safely and effectively. See full prescribing information for TOPIRAMATE tablets, USP. TOPIRAMATE tablets USP, for oral Use. Initial U.S. Approval: 1996
68071-1971-62021-02-23C16284748780-1ba0f9c33-4e26-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use TOPIRAMATE tablets, USP safely and effectively. See full prescribing information for TOPIRAMATE tablets, USP. TOPIRAMATE tablets USP, for oral Use. Initial U.S. Approval: 1996
68071-1971-92021-02-23C16284748780-1ba0f9c33-4e26-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use TOPIRAMATE tablets, USP safely and effectively. See full prescribing information for TOPIRAMATE tablets, USP. TOPIRAMATE tablets USP, for oral Use. Initial U.S. Approval: 1996
68071-1971-32021-01-29C16284748780-1ba0f9c33-4e26-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use TOPIRAMATE tablets, USP safely and effectively. See full prescribing information for TOPIRAMATE tablets, USP. TOPIRAMATE tablets USP, for oral Use. Initial U.S. Approval: 1996
68071-1971-62021-01-29C16284748780-1ba0f9c33-4e26-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use TOPIRAMATE tablets, USP safely and effectively. See full prescribing information for TOPIRAMATE tablets, USP. TOPIRAMATE tablets USP, for oral Use. Initial U.S. Approval: 1996
68071-1971-92021-01-29C16284748780-1ba0f9c33-4e26-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use TOPIRAMATE tablets, USP safely and effectively. See full prescribing information for TOPIRAMATE tablets, USP. TOPIRAMATE tablets USP, for oral Use. Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-1971-3Topiramate30 in 1 BOTTLETABLET306
68071-1971-6Topiramate60 in 1 BOTTLETABLET606
68071-1971-9Topiramate90 in 1 BOTTLETABLET906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-1971TOPIRAMATE TABLET [NUCARE PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 3 package rows20240717_490f109f-30cb-0790-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199888topiramate 25 MG Oral TabletPSN490f109f-30cb-0790-e054-00144ff88e886
199888topiramate 25 MG Oral TabletSCD490f109f-30cb-0790-e054-00144ff88e886

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-1971-36807119710330 TABLET in 1 BOTTLE (68071-1971-3) 30 tablet2017-02-210000-00-00NoNoCurrent
68071-1971-66807119710660 TABLET in 1 BOTTLE (68071-1971-6) 60 tablet2017-02-210000-00-00NoNoCurrent
68071-1971-96807119710990 TABLET in 1 BOTTLE (68071-1971-9) 90 tablet2017-02-210000-00-00NoNoCurrent