FDA.reportPublic FDA data

Topiramate

Product NDC
80425-0373
11-digit product format
804250373
Labeler code
80425
Product ID
80425-0373_10a898a2-543a-9e04-e063-6294a90a7731
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Topiramate
Dosage form
TABLET
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA076343
Marketing category
ANDA
Marketing start
2024-02-05
Substance
TOPIRAMATE
Active strength
100 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
TOPIRAMATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0H73WJJ391
Rxcui199889

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
80425-0373-1Topiramate30 in 1 BOTTLETABLET301
80425-0373-2Topiramate60 in 1 BOTTLETABLET601
80425-0373-3Topiramate90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0373-1EA - Each80425-0373fa4657a6-be9a-42cf-a630-eb77ffcdcff312024-03-12
80425-0373-2EA - Each80425-0373852a5f0c-084d-4179-b4ad-6c14af853b6e12024-03-12
80425-0373-3EA - Each80425-0373cee8e2da-2d40-4020-9711-1888429d020c12024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0373TOPIRAMATE TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]1Current NDC, 3 package rows20240206_10a9e6fa-4d55-6b5c-e063-6294a90a608c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199889topiramate 100 MG Oral TabletPSN10a9e6fa-4d55-6b5c-e063-6294a90a608c1
199889topiramate 100 MG Oral TabletSCD10a9e6fa-4d55-6b5c-e063-6294a90a608c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0373-18042503730130 TABLET in 1 BOTTLE (80425-0373-1) 30 tablet2024-02-05NoNoHistorical
80425-0373-28042503730260 TABLET in 1 BOTTLE (80425-0373-2) 60 tablet2024-02-05NoNoHistorical
80425-0373-38042503730390 TABLET in 1 BOTTLE (80425-0373-3) 90 tablet2024-02-05NoNoHistorical