FDA.reportPublic FDA data

Topiramate

Product NDC
51655-606
11-digit product format
516550606
Labeler code
51655
Product ID
51655-606_4b805f18-ffd5-d938-e063-6294a90a3a3a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Topiramate
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA076343
Marketing category
ANDA
Marketing start
2020-05-28
Substance
TOPIRAMATE
Active strength
50 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
TOPIRAMATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0H73WJJ391
Rxcui151226

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
51655-606-262023-04-18C16284748780-1f386c64a-41d8-0266-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
51655-606-262023-01-30C16284748780-1f386c64a-41d8-0266-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
51655-606-26Topiramate90 in 1 BOTTLE, PLASTICTABLET904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-606TOPIRAMATE TABLET [NORTHWIND PHARMACEUTICALS, LLC]3Current NDC, Legacy NDC, 1 package rows20241228_ca45d478-7214-5bc7-e053-2995a90aa601.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
151226topiramate 50 MG Oral TabletPSNca45d478-7214-5bc7-e053-2995a90aa6014
151226topiramate 50 MG Oral TabletSCDca45d478-7214-5bc7-e053-2995a90aa6014

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51655-606-265165506062690 TABLET in 1 BOTTLE, PLASTIC (51655-606-26) 90 tablet2020-05-280000-00-00NoNoCurrent