FDA.reportPublic FDA data

Topiramate

Product NDC
50090-3931
11-digit product format
500903931
Labeler code
50090
Product ID
50090-3931_9f4895d0-c08e-4320-9380-0e37860d596f
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
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
50090-3931-02023-01-30C16284748780-1f386c64a-1736-0266-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
50090-3931-12023-01-30C16284748780-1f386c64a-1736-0266-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
50090-3931-22023-01-30C16284748780-1f386c64a-1736-0266-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
50090-3931-0Topiramate60 in 1 BOTTLETABLET, FILM COATED606
50090-3931-1Topiramate90 in 1 BOTTLE, PLASTICTABLET, FILM COATED906
50090-3931-2Topiramate30 in 1 BOTTLE, PLASTICTABLET, FILM COATED306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3931-0EA - Each50090-39316e41a3f1-be91-4d0d-bc54-ba0e9dc0137812021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3931TOPIRAMATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]6Legacy NDC, 3 package rows20210417_969706ca-698c-4899-977b-e807adf3ad10.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199888topiramate 25 MG Oral TabletPSN969706ca-698c-4899-977b-e807adf3ad106
199888topiramate 25 MG Oral TabletSCD969706ca-698c-4899-977b-e807adf3ad106

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3931-05009039310060 TABLET, FILM COATED in 1 BOTTLE (50090-3931-0) 2018-12-070000-00-00NoNoCurrent
50090-3931-15009039310190 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3931-1) 2014-12-150000-00-00NoNoCurrent
50090-3931-25009039310230 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3931-2) 2014-12-150000-00-00NoNoCurrent