FDA.reportPublic FDA data

topiramate

Product NDC
80425-0576
11-digit product format
804250576
Labeler code
80425
Product ID
80425-0576_4b1d2489-5bd8-ead3-e063-6294a90af6f8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
topiramate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA090162
Marketing category
ANDA
Marketing start
2026-02-18
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
topiramate
Listing expiration
2027-12-31

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
80425-0576-1topiramate30 in 1 BOTTLE, PLASTICTABLET, FILM COATED301
80425-0576-2topiramate60 in 1 BOTTLE, PLASTICTABLET, FILM COATED601
80425-0576-3topiramate90 in 1 BOTTLE, PLASTICTABLET, FILM COATED901
80425-0576-4topiramate270 in 1 BOTTLE, PLASTICTABLET, FILM COATED2701

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0576-1EA - Each80425-05764c2efcba-8117-418d-ad33-1abc2522e1c112026-03-17
80425-0576-2EA - Each80425-05767383b1aa-032b-4aa3-9cfe-88f25f7fb40912026-03-17
80425-0576-3EA - Each80425-0576be2f4cc4-0af2-48cf-9af9-34724eb7519012026-03-17
80425-0576-4EA - Each80425-05768f4f3540-5954-4c75-b6df-3333d9ad9b2f12026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199888topiramate 25 MG Oral TabletPSN4b1d3130-cf3c-d7da-e063-6294a90a60791
199888topiramate 25 MG Oral TabletSCD4b1d3130-cf3c-d7da-e063-6294a90a60791

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
80425-0576-18042505760130 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0576-1) 2026-02-18NoNoHistorical
80425-0576-28042505760260 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0576-2) 2026-02-18NoNoHistorical
80425-0576-38042505760390 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0576-3) 2026-02-18NoNoHistorical
80425-0576-480425057604270 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0576-4) 2026-02-18NoNoHistorical