FDA.reportPublic FDA data

Topiramate

Product NDC
50090-3461
11-digit product format
500903461
Labeler code
50090
Product ID
50090-3461_c3bc6965-397a-4657-ae62-c05a29568265
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Topiramate
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA076343
Marketing category
ANDA
Marketing start
2014-06-12
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, 199889

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3461-02023-11-21C16284748780-1f386c64a-3aac-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996
50090-3461-12023-11-21C16284748780-1f386c64a-3aac-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996
50090-3461-22023-11-21C16284748780-1f386c64a-3aac-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996
50090-3461-02023-01-30C16284748780-1f386c64a-3aac-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996
50090-3461-12023-01-30C16284748780-1f386c64a-3aac-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996
50090-3461-22023-01-30C16284748780-1f386c64a-3aac-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3461-0Topiramate60 in 1 BOTTLETABLET6026
50090-3461-1Topiramate90 in 1 BOTTLETABLET9026
50090-3461-2Topiramate120 in 1 BOTTLETABLET12026
50090-3461-3Topiramate180 in 1 BOTTLETABLET18026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3461-0EA - Each50090-3461cc68aea9-00b9-40c2-8862-1b92d50d3be612019-05-02
50090-3461-1EA - Each50090-34610cf5fb62-a7cd-4d5a-a9a8-4cb07bc5232112019-05-02
50090-3461-2EA - Each50090-346169305847-b1bb-4473-91a7-9a370ba0873112019-05-02
50090-3461-3EA - Each50090-34619d5a0cf1-8f2d-483f-94f7-d4161459b12012023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3461TOPIRAMATE TABLET [A-S MEDICATION SOLUTIONS]24Current NDC, Legacy NDC, 4 package rows20250216_f16b14a2-297f-4adb-8d7a-5f43785faef7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199889topiramate 100 MG Oral TabletPSNf16b14a2-297f-4adb-8d7a-5f43785faef726
151226topiramate 50 MG Oral TabletPSNf16b14a2-297f-4adb-8d7a-5f43785faef726
199889topiramate 100 MG Oral TabletSCDf16b14a2-297f-4adb-8d7a-5f43785faef726
151226topiramate 50 MG Oral TabletSCDf16b14a2-297f-4adb-8d7a-5f43785faef726

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3461-05009034610060 TABLET in 1 BOTTLE (50090-3461-0) 60 tablet2018-05-220000-00-00NoNoCurrent
50090-3461-15009034610190 TABLET in 1 BOTTLE (50090-3461-1) 90 tablet2018-05-230000-00-00NoNoCurrent
50090-3461-250090346102120 TABLET in 1 BOTTLE (50090-3461-2) 120 tablet2018-06-040000-00-00NoNoCurrent
50090-3461-350090346103180 TABLET in 1 BOTTLE (50090-3461-3) 180 tablet2023-11-20NoNoHistorical