FDA.reportPublic FDA data

topiramate

Product NDC
68071-4793
11-digit product format
680714793
Labeler code
68071
Product ID
68071-4793_bb8e2ac0-ff51-a9c1-e053-2a95a90ab3be
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
topiramate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA078235
Marketing category
ANDA
Marketing start
2009-03-27
Marketing end
0000-00-00
Substance
TOPIRAMATE
Active strength
25 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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
68071-4793-32023-01-30C16284748780-1ba0f9c33-4356-a910-e053-dadaa90a0b85These 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
68071-4793-32021-02-17C16284748780-1ba0f9c33-4356-a910-e053-dadaa90a0b85These 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
68071-4793-32021-01-29C16284748780-1ba0f9c33-4356-a910-e053-dadaa90a0b85These 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
68071-4793-3topiramate30 in 1 BOTTLETABLET, FILM COATED302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4793TOPIRAMATE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]2Legacy NDC, 1 package rows20210219_835e5fa5-c602-8787-e053-2991aa0a7ba5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199888topiramate 25 MG Oral TabletPSN835e5fa5-c602-8787-e053-2991aa0a7ba52
199888topiramate 25 MG Oral TabletSCD835e5fa5-c602-8787-e053-2991aa0a7ba52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-4793-36807147930330 TABLET, FILM COATED in 1 BOTTLE (68071-4793-3) 2019-03-050000-00-00NoNoCurrent