FDA.reportPublic FDA data

Topiramate

Product NDC
80425-0092
11-digit product format
804250092
Labeler code
80425
Product ID
80425-0092_1faa2b61-b53d-b7b0-e063-6394a90a8712
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Topiramate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA078235
Marketing category
ANDA
Marketing start
2009-03-27
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
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0092-1Topiramate30 in 1 BOTTLETABLET, FILM COATED306
80425-0092-2Topiramate60 in 1 BOTTLETABLET, FILM COATED606
80425-0092-3Topiramate90 in 1 BOTTLETABLET, FILM COATED906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0092-1EA - Each80425-0092dc46d04c-8663-4a71-a352-20b2eeb8e56c12023-04-07
80425-0092-2EA - Each80425-0092724ff281-91b6-4725-85c2-247bef520c6c12023-04-07
80425-0092-3EA - Each80425-0092818b3755-f54d-42d9-b198-0bb9a0c2cb7c12024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0092TOPIRAMATE TABLET, FILM COATED [ADVANCED RX PHARMACY OF TENNESSEE, LLC]6Current NDC, Legacy NDC, 3 package rows20240816_b353e7fb-b976-96d8-e053-2995a90a110a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
151226topiramate 50 MG Oral TabletPSNb353e7fb-b976-96d8-e053-2995a90a110a6
151226topiramate 50 MG Oral TabletSCDb353e7fb-b976-96d8-e053-2995a90a110a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
80425-0092-18042500920130 TABLET, FILM COATED in 1 BOTTLE (80425-0092-1) 2009-03-27NoNoHistorical
80425-0092-28042500920260 TABLET, FILM COATED in 1 BOTTLE (80425-0092-2) 2009-03-270000-00-00NoNoCurrent
80425-0092-38042500920390 TABLET, FILM COATED in 1 BOTTLE (80425-0092-3) 2024-08-14NoNoHistorical