FDA.reportPublic FDA data

topiramate

Product NDC
50436-0139
11-digit product format
504360139
Labeler code
50436
Product ID
50436-0139_9327804a-3908-401b-9b06-a55d9b630462
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
topiramate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA078235
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
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50436-0139-12021-01-29C16284748780-1ba0f9c33-4b6e-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
50436-0139-22021-01-29C16284748780-1ba0f9c33-4b6e-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
50436-0139-32021-01-29C16284748780-1ba0f9c33-4b6e-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
50436-0139-1topiramate30 in 1 BOTTLETABLET, FILM COATED304
50436-0139-2topiramate60 in 1 BOTTLETABLET, FILM COATED604
50436-0139-3topiramate90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-0139-1EA - Each50436-0139987b3473-aa75-4e74-a8be-30921c6f54a312017-08-11
50436-0139-2EA - Each50436-0139e380fb55-ff87-4773-93c4-1bae4ead148a12017-08-11
50436-0139-3EA - Each50436-013995018442-2ce6-44ae-aae3-2088097c9e1212017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0139TOPIRAMATE TABLET, FILM COATED [UNIT DOSE SERVICES]4Legacy NDC, 3 package rows20171108_033a2eb1-aba2-410b-8b9e-fafbc789ffa3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
151226topiramate 50 MG Oral TabletPSN033a2eb1-aba2-410b-8b9e-fafbc789ffa34
151226topiramate 50 MG Oral TabletSCD033a2eb1-aba2-410b-8b9e-fafbc789ffa34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-0139-15043601390130 in 1 BOTTLEHistorical
50436-0139-25043601390260 in 1 BOTTLEHistorical
50436-0139-35043601390390 in 1 BOTTLEHistorical