FDA.reportPublic FDA data

Topiramate

Product NDC
50436-9952
11-digit product format
504369952
Labeler code
50436
Product ID
50436-9952_72ead1c8-4794-4510-b056-a16682da2f76
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Topiramate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA090278
Marketing category
ANDA
Marketing start
2009-03-27
Marketing end
0000-00-00
Substance
TOPIRAMATE
Active strength
200 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
2020-12-31
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
50436-9952-22021-01-29C16284748780-1ba0f9c33-36c6-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use TOPIRAMATE tablets 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
50436-9952-2Topiramate60 in 1 BOTTLETABLET, FILM COATED604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-9952-2EA - Each50436-99528fb7b506-edfc-4feb-8a83-0ffee0f7ec7112015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOPIRAMATEACTIVE INGREDIENT0H73WJJ391TOPIRAMATE TABLET, FILM COATED [UNIT DOSE SERVICES]2
TOPIRAMATEACTIVE MOIETY0H73WJJ391TOPIRAMATE TABLET, FILM COATED [UNIT DOSE SERVICES]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTOPIRAMATE TABLET, FILM COATED [UNIT DOSE SERVICES]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTOPIRAMATE TABLET, FILM COATED [UNIT DOSE SERVICES]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TOPIRAMATE TABLET, FILM COATED [UNIT DOSE SERVICES]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TOPIRAMATE TABLET, FILM COATED [UNIT DOSE SERVICES]2
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62TOPIRAMATE TABLET, FILM COATED [UNIT DOSE SERVICES]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TOPIRAMATE TABLET, FILM COATED [UNIT DOSE SERVICES]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATOPIRAMATE TABLET, FILM COATED [UNIT DOSE SERVICES]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990TOPIRAMATE TABLET, FILM COATED [UNIT DOSE SERVICES]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TOPIRAMATE TABLET, FILM COATED [UNIT DOSE SERVICES]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTOPIRAMATE TABLET, FILM COATED [UNIT DOSE SERVICES]2
TALCINACTIVE INGREDIENT7SEV7J4R1UTOPIRAMATE TABLET, FILM COATED [UNIT DOSE SERVICES]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTOPIRAMATE TABLET, FILM COATED [UNIT DOSE SERVICES]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-9952TOPIRAMATE TABLET, FILM COATED [UNIT DOSE SERVICES]4Legacy NDC, 1 package rows20170312_5f03d5e8-8f65-42cd-bbef-707def83905c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199890topiramate 200 MG Oral TabletPSN5f03d5e8-8f65-42cd-bbef-707def83905c4
199890topiramate 200 MG Oral TabletSCD5f03d5e8-8f65-42cd-bbef-707def83905c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-9952-25043699520260 in 1 BOTTLEHistorical