FDA.reportPublic FDA data

Topiramate

Product NDC
71335-0925
11-digit product format
713350925
Labeler code
71335
Product ID
71335-0925_192309c7-4225-4515-93ac-94d05a0ad015
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Topiramate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090278
Marketing category
ANDA
Marketing start
2014-12-15
Substance
TOPIRAMATE
Active strength
200 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Topiramate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOPIRAMATE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0H73WJJ391
Rxcui199890

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0925-1Topiramate30 in 1 BOTTLETABLET, FILM COATED30102
71335-0925-2Topiramate60 in 1 BOTTLETABLET, FILM COATED60102
71335-0925-3Topiramate90 in 1 BOTTLETABLET, FILM COATED90102
71335-0925-4Topiramate120 in 1 BOTTLETABLET, FILM COATED120102
71335-0925-5Topiramate28 in 1 BOTTLETABLET, FILM COATED28102
71335-0925-6Topiramate20 in 1 BOTTLETABLET, FILM COATED20102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0925TOPIRAMATE TABLET, FILM COATED [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 6 package rows20240410_47ef2964-3a41-4bfd-86fb-d44560b9961f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199890topiramate 200 MG Oral TabletPSN47ef2964-3a41-4bfd-86fb-d44560b9961f102
199890topiramate 200 MG Oral TabletSCD47ef2964-3a41-4bfd-86fb-d44560b9961f102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0925-17133509250130 TABLET, FILM COATED in 1 BOTTLE (71335-0925-1) 2019-03-010000-00-00NoNoCurrent
71335-0925-27133509250260 TABLET, FILM COATED in 1 BOTTLE (71335-0925-2) 2018-08-100000-00-00NoNoCurrent
71335-0925-37133509250390 TABLET, FILM COATED in 1 BOTTLE (71335-0925-3) 2024-04-040000-00-00NoNoCurrent
71335-0925-471335092504120 TABLET, FILM COATED in 1 BOTTLE (71335-0925-4) 2024-04-040000-00-00NoNoCurrent
71335-0925-57133509250528 TABLET, FILM COATED in 1 BOTTLE (71335-0925-5) 2024-04-040000-00-00NoNoCurrent
71335-0925-67133509250620 TABLET, FILM COATED in 1 BOTTLE (71335-0925-6) 2024-04-04NoNoCurrent