FDA.reportPublic FDA data

Topiramate

Product NDC
50090-3932
11-digit product format
500903932
Labeler code
50090
Product ID
50090-3932_b03c72f9-a726-491e-b124-af5f52f69c8c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Topiramate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090278
Marketing category
ANDA
Marketing start
2014-12-15
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
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
50090-3932-02023-01-30C16284748780-1f386c64a-1616-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996
50090-3932-12023-01-30C16284748780-1f386c64a-1616-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996
50090-3932-22023-01-30C16284748780-1f386c64a-1616-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3932-0Topiramate60 in 1 BOTTLETABLET, FILM COATED606
50090-3932-1Topiramate90 in 1 BOTTLETABLET, FILM COATED906
50090-3932-2Topiramate120 in 1 BOTTLETABLET, FILM COATED1206

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3932TOPIRAMATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]6Legacy NDC, 3 package rows20210417_6f2dcfd9-b4c2-4c06-abe5-8616632e525f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
151226topiramate 50 MG Oral TabletPSN6f2dcfd9-b4c2-4c06-abe5-8616632e525f6
151226topiramate 50 MG Oral TabletSCD6f2dcfd9-b4c2-4c06-abe5-8616632e525f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3932-05009039320060 TABLET, FILM COATED in 1 BOTTLE (50090-3932-0) 2018-12-070000-00-00NoNoCurrent
50090-3932-15009039320190 TABLET, FILM COATED in 1 BOTTLE (50090-3932-1) 2018-12-070000-00-00NoNoCurrent
50090-3932-250090393202120 TABLET, FILM COATED in 1 BOTTLE (50090-3932-2) 2018-12-070000-00-00NoNoCurrent