FDA.reportPublic FDA data

TOPIRAMATE

Product NDC
52959-994
11-digit product format
529590994
Labeler code
52959
Product ID
52959-994_7e3a6da2-f432-4a62-ab53-c305587b7726
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
topiramate
Dosage form
TABLET
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA079153
Marketing category
ANDA
Marketing start
2009-03-27
Marketing end
0000-00-00
Substance
TOPIRAMATE
Active strength
50 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
E
Listing certified through
2017-12-31
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
52959-994-022019-11-13C16284748780-197449f38-bd6e-f6ea-e053-dbdaa90aa703These highlights do not include all the information needed to use topiramate tablets safely and effectively. See full prescribing information for topiramate tablets Topiramate Tablets Rx Only Initial U.S. Approval - 1996
52959-994-302019-11-13C16284748780-197449f38-bd6e-f6ea-e053-dbdaa90aa703These highlights do not include all the information needed to use topiramate tablets safely and effectively. See full prescribing information for topiramate tablets Topiramate Tablets Rx Only Initial U.S. Approval - 1996
52959-994-602019-11-13C16284748780-197449f38-bd6e-f6ea-e053-dbdaa90aa703These highlights do not include all the information needed to use topiramate tablets safely and effectively. See full prescribing information for topiramate tablets Topiramate Tablets Rx Only Initial U.S. Approval - 1996
52959-994-902019-11-13C16284748780-197449f38-bd6e-f6ea-e053-dbdaa90aa703These highlights do not include all the information needed to use topiramate tablets safely and effectively. See full prescribing information for topiramate tablets Topiramate Tablets Rx Only Initial U.S. Approval - 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-994-02TOPIRAMATE120 in 1 BOTTLETABLET1203
52959-994-30TOPIRAMATE30 in 1 BOTTLETABLET303
52959-994-60TOPIRAMATE60 in 1 BOTTLETABLET603
52959-994-90TOPIRAMATE90 in 1 BOTTLETABLET903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-994TOPIRAMATE ( TOPIRAMATE ) TABLET [H.J. HARKINS COMPANY, INC.]3Legacy NDC, 4 package rows20120120_546130a3-e5f2-422d-88f0-66de19540ecb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199888topiramate 25 MG Oral TabletPSN546130a3-e5f2-422d-88f0-66de19540ecb3
151226topiramate 50 MG Oral TabletPSN546130a3-e5f2-422d-88f0-66de19540ecb3
199888topiramate 25 MG Oral TabletSCD546130a3-e5f2-422d-88f0-66de19540ecb3
151226topiramate 50 MG Oral TabletSCD546130a3-e5f2-422d-88f0-66de19540ecb3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-994-0252959099402120 in 1 BOTTLEHistorical
52959-994-305295909943030 in 1 BOTTLEHistorical
52959-994-605295909946060 in 1 BOTTLEHistorical
52959-994-905295909949090 in 1 BOTTLEHistorical