FDA.reportPublic FDA data

topiramate

Product NDC
50090-5309
11-digit product format
500905309
Labeler code
50090
Product ID
50090-5309_3a4d1f5a-8e48-45a1-944a-5e49c6db501c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
topiramate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078235
Marketing category
ANDA
Marketing start
2009-03-27
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
50090-5309-0topiramate60 in 1 BOTTLETABLET, FILM COATED6010
50090-5309-1topiramate30 in 1 BOTTLETABLET, FILM COATED3010
50090-5309-2topiramate90 in 1 BOTTLETABLET, FILM COATED9010
50090-5309-3topiramate180 in 1 BOTTLETABLET, FILM COATED18010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5309-0EA - Each50090-53093913e61d-12af-4aee-b1c6-a6480d7efa2512023-01-09
50090-5309-1EA - Each50090-530931342113-e492-432b-9cfb-197ae7e0bd3412023-01-09
50090-5309-2EA - Each50090-53091014de82-c8aa-4fd7-a9d2-b2ac75497cb012023-01-09
50090-5309-3EA - Each50090-53097c3070b0-bf19-4e9c-93e9-cce107ba13c612023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5309TOPIRAMATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]8Current NDC, Legacy NDC, 4 package rows20230912_674c2c2e-014a-43a1-91a7-7214ffc4b1d7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199889topiramate 100 MG Oral TabletPSN674c2c2e-014a-43a1-91a7-7214ffc4b1d710
199889topiramate 100 MG Oral TabletSCD674c2c2e-014a-43a1-91a7-7214ffc4b1d710

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5309-05009053090060 TABLET, FILM COATED in 1 BOTTLE (50090-5309-0) 2020-10-280000-00-00NoNoCurrent
50090-5309-15009053090130 TABLET, FILM COATED in 1 BOTTLE (50090-5309-1) 2020-10-280000-00-00NoNoCurrent
50090-5309-25009053090290 TABLET, FILM COATED in 1 BOTTLE (50090-5309-2) 2020-10-280000-00-00NoNoCurrent
50090-5309-350090530903180 TABLET, FILM COATED in 1 BOTTLE (50090-5309-3) 2022-03-100000-00-00NoNoCurrent