FDA.reportPublic FDA data

topiramate

Product NDC
68788-7460
11-digit product format
687887460
Labeler code
68788
Product ID
68788-7460_6db355d5-503b-4993-963b-95c22c345ec4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
topiramate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA078235
Marketing category
ANDA
Marketing start
2009-03-27
Substance
TOPIRAMATE
Active strength
25 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
TOPIRAMATE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0H73WJJ391
Rxcui199888

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
68788-7460-3topiramate30 in 1 BOTTLETABLET, FILM COATED307
68788-7460-5topiramate15 in 1 BOTTLETABLET, FILM COATED157
68788-7460-6topiramate60 in 1 BOTTLETABLET, FILM COATED607
68788-7460-8topiramate120 in 1 BOTTLETABLET, FILM COATED1207
68788-7460-9topiramate90 in 1 BOTTLETABLET, FILM COATED907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7460-3EA - Each68788-7460e7806559-47e9-4da9-ae04-50079637d73112020-04-20
68788-7460-6EA - Each68788-74607f449527-ed04-4163-bbdf-c4c221ed8df712020-04-20
68788-7460-9EA - Each68788-746045b3f152-056f-4850-a244-66989cc2b62412020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7460TOPIRAMATE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 5 package rows20240822_d8454fdf-7b34-49c0-b130-732e39b774b2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199888topiramate 25 MG Oral TabletPSNd8454fdf-7b34-49c0-b130-732e39b774b27
199888topiramate 25 MG Oral TabletSCDd8454fdf-7b34-49c0-b130-732e39b774b27

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7460-36878874600330 TABLET, FILM COATED in 1 BOTTLE (68788-7460-3) 2019-12-270000-00-00NoNoCurrent
68788-7460-56878874600515 TABLET, FILM COATED in 1 BOTTLE (68788-7460-5) 2019-12-270000-00-00NoNoCurrent
68788-7460-66878874600660 TABLET, FILM COATED in 1 BOTTLE (68788-7460-6) 2019-12-270000-00-00NoNoCurrent
68788-7460-868788746008120 TABLET, FILM COATED in 1 BOTTLE (68788-7460-8) 2021-09-210000-00-00NoNoCurrent
68788-7460-96878874600990 TABLET, FILM COATED in 1 BOTTLE (68788-7460-9) 2019-12-270000-00-00NoNoCurrent