FDA.reportPublic FDA data

Topiramate

Product NDC
80425-0214
11-digit product format
804250214
Labeler code
80425
Product ID
80425-0214_2a9aa671-d0a0-2254-e063-6294a90a9f79
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Topiramate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA090162
Marketing category
ANDA
Marketing start
2023-01-03
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
80425-0214-1Topiramate30 in 1 BOTTLETABLET, FILM COATED304
80425-0214-2Topiramate60 in 1 BOTTLETABLET, FILM COATED604
80425-0214-3Topiramate90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0214-1EA - Each80425-02143a7091d9-0d5a-4f7b-87b2-1e14d4ff3f7912023-07-06
80425-0214-2EA - Each80425-0214bfe5cc69-2d23-4ede-a315-e0973c61bc3f12023-04-07
80425-0214-3EA - Each80425-0214452b3e58-9cb6-4970-b3ff-ab482bdfae7312023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0214TOPIRAMATE TABLET, FILM COATED [ADVANCED RX PHARMACY OF TENNESSEE, LLC]4Current NDC, 3 package rows20250102_f16065c0-9949-9ac4-e053-2995a90a3b02.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
151226topiramate 50 MG Oral TabletPSNf16065c0-9949-9ac4-e053-2995a90a3b024
151226topiramate 50 MG Oral TabletSCDf16065c0-9949-9ac4-e053-2995a90a3b024

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
80425-0214-18042502140130 TABLET, FILM COATED in 1 BOTTLE (80425-0214-1) 2023-01-03NoNoHistorical
80425-0214-28042502140260 TABLET, FILM COATED in 1 BOTTLE (80425-0214-2) 2023-01-03NoNoHistorical
80425-0214-38042502140390 TABLET, FILM COATED in 1 BOTTLE (80425-0214-3) 2023-01-03NoNoHistorical