FDA.reportPublic FDA data

topiramate

Product NDC
60760-075
11-digit product format
607600075
Labeler code
60760
Product ID
60760-075_3cd0de0b-c112-1b86-e063-6294a90af536
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
topiramate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ST. MARY'S MEDICAL PARK PHARMACY
Application
ANDA078235
Marketing category
ANDA
Marketing start
2019-09-05
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60760-075-602023-12-13C16284748780-1f386c64a-214e-0266-e053-dadaa90a7c1aThese 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
60760-075-602023-01-30C16284748780-1f386c64a-214e-0266-e053-dadaa90a7c1aThese 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
60760-075-30topiramate30 in 1 BOTTLE, PLASTICTABLET, FILM COATED304
60760-075-60topiramate60 in 1 BOTTLE, PLASTICTABLET, FILM COATED604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-075-30EA - Each60760-0751532c173-33d1-42a8-b331-a54c4650005e12025-09-12
60760-075-60EA - Each60760-07537e807ac-c5f1-457e-bee0-a4fc6ee60b8312019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-075TOPIRAMATE TABLET, FILM COATED [ST. MARY'S MEDICAL PARK PHARMACY]3Current NDC, Legacy NDC, 2 package rows20240509_9221403c-467f-738e-e053-2995a90ac8fd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199888topiramate 25 MG Oral TabletPSN9221403c-467f-738e-e053-2995a90ac8fd4
199888topiramate 25 MG Oral TabletSCD9221403c-467f-738e-e053-2995a90ac8fd4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60760-075-306076000753030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-075-30) 2025-08-20NoNoCurrent
60760-075-606076000756060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-075-60) 2019-09-050000-00-00NoNoCurrent