FDA.reportPublic FDA data

Topiramate

Product NDC
51655-608
11-digit product format
516550608
Labeler code
51655
Product ID
51655-608_4b809f46-07c3-68fd-e063-6394a90a3fab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Topiramate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA077627
Marketing category
ANDA
Marketing start
2015-02-02
Substance
TOPIRAMATE
Active strength
100 mg/1
Pharmacologic classes
Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Topiramate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOPIRAMATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0H73WJJ391
Rxcui199889

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
51655-608-262026-01-29C16284748780-19d75b9d0-5a7f-f424-e053-dadaa90a57ceThese 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
51655-608-522026-01-29C16284748780-19d75b9d0-5a7f-f424-e053-dadaa90a57ceThese 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
51655-608-262023-04-17C16284748780-19d75b9d0-5a7f-f424-e053-dadaa90a57ceThese 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
51655-608-522023-04-17C16284748780-19d75b9d0-5a7f-f424-e053-dadaa90a57ceThese 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
51655-608-262020-01-31C16284748780-19d75b9d0-5a7f-f424-e053-dadaa90a57ceThese 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
51655-608-522020-01-31C16284748780-19d75b9d0-5a7f-f424-e053-dadaa90a57ceThese 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
51655-608-26Topiramate90 in 1 BOTTLE, DISPENSINGTABLET, FILM COATED905
51655-608-52Topiramate30 in 1 BOTTLE, DISPENSINGTABLET, FILM COATED305

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOPIRAMATEACTIVE INGREDIENT0H73WJJ391TOPIRAMATE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]1
TOPIRAMATEACTIVE MOIETY0H73WJJ391TOPIRAMATE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-608TOPIRAMATE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]3Current NDC, Legacy NDC, 2 package rows20241228_ae63e0e2-ceb1-4cc7-88fa-92cfa4516960.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199889topiramate 100 MG Oral TabletPSNae63e0e2-ceb1-4cc7-88fa-92cfa45169605
199889topiramate 100 MG Oral TabletSCDae63e0e2-ceb1-4cc7-88fa-92cfa45169605

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51655-608-265165506082690 TABLET, FILM COATED in 1 BOTTLE, DISPENSING (51655-608-26) 2015-02-02NoNoHistorical
51655-608-525165506085230 TABLET, FILM COATED in 1 BOTTLE, DISPENSING (51655-608-52) 2015-02-02NoNoHistorical