FDA.reportPublic FDA data

topiramate

Product NDC
71335-1116
11-digit product format
713351116
Labeler code
71335
Product ID
71335-1116_5a7c12c7-b931-4ced-95d6-0298c8e45b40
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
topiramate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078235
Marketing category
ANDA
Marketing start
2009-03-27
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
71335-1116-1topiramate30 in 1 BOTTLETABLET, FILM COATED307
71335-1116-2topiramate60 in 1 BOTTLETABLET, FILM COATED607
71335-1116-3topiramate90 in 1 BOTTLETABLET, FILM COATED907
71335-1116-4topiramate120 in 1 BOTTLETABLET, FILM COATED1207
71335-1116-5topiramate28 in 1 BOTTLETABLET, FILM COATED287
71335-1116-6topiramate20 in 1 BOTTLETABLET, FILM COATED207

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1116-1EA - Each71335-11160ba12324-2caa-46d1-9c69-a0f6c2d965b612022-04-06
71335-1116-2EA - Each71335-111646cb91d9-a832-40c0-91a5-a928bca7e11612022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1116TOPIRAMATE TABLET, FILM COATED [BRYANT RANCH PREPACK]7Current NDC, Legacy NDC, 6 package rows20231102_8abe45eb-cc75-4625-ae3d-5b2a038c4907.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199890topiramate 200 MG Oral TabletPSN8abe45eb-cc75-4625-ae3d-5b2a038c49077
199890topiramate 200 MG Oral TabletSCD8abe45eb-cc75-4625-ae3d-5b2a038c49077

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1116-17133511160130 TABLET, FILM COATED in 1 BOTTLE (71335-1116-1) 2020-10-220000-00-00NoNoCurrent
71335-1116-27133511160260 TABLET, FILM COATED in 1 BOTTLE (71335-1116-2) 2019-02-220000-00-00NoNoCurrent
71335-1116-37133511160390 TABLET, FILM COATED in 1 BOTTLE (71335-1116-3) 2022-07-080000-00-00NoNoCurrent
71335-1116-471335111604120 TABLET, FILM COATED in 1 BOTTLE (71335-1116-4) 2022-07-080000-00-00NoNoCurrent
71335-1116-57133511160528 TABLET, FILM COATED in 1 BOTTLE (71335-1116-5) 2022-07-080000-00-00NoNoCurrent
71335-1116-67133511160620 TABLET, FILM COATED in 1 BOTTLE (71335-1116-6) 2022-07-080000-00-00NoNoCurrent