FDA.reportPublic FDA data

topiramate

Product NDC
51655-848
11-digit product format
516550848
Labeler code
51655
Product ID
51655-848_4c4735c6-bf5b-9cfe-e063-6294a90a8f6e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
topiramate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA078235
Marketing category
ANDA
Marketing start
2023-02-06
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
51655-848-262026-01-29C16284748780-149896155-c2b0-586f-e063-e6dba90add90These 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
51655-848-522026-01-29C16284748780-149896155-c2b0-586f-e063-e6dba90add90These 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
51655-848-26topiramate90 in 1 BOTTLE, PLASTICTABLET, FILM COATED903
51655-848-52topiramate30 in 1 BOTTLE, PLASTICTABLET, FILM COATED303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-848TOPIRAMATE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]2Current NDC, 2 package rows20240810_ffd7be08-050e-dfcb-e053-6394a90ad286.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199889topiramate 100 MG Oral TabletPSNffd7be08-050e-dfcb-e053-6394a90ad2863
199889topiramate 100 MG Oral TabletSCDffd7be08-050e-dfcb-e053-6394a90ad2863

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51655-848-265165508482690 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-848-26) 2023-04-17NoNoHistorical
51655-848-525165508485230 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-848-52) 2023-02-06NoNoHistorical