FDA.reportPublic FDA data

Topiramate

Product NDC
50090-4614
11-digit product format
500904614
Labeler code
50090
Product ID
50090-4614_3c2cea8a-2805-4919-80f5-0bb2a6d12229
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4614-02023-11-21C16284748780-1f386c64a-3b1f-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
50090-4614-12023-11-21C16284748780-1f386c64a-3b1f-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
50090-4614-22023-11-21C16284748780-1f386c64a-3b1f-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
50090-4614-02023-01-30C16284748780-1f386c64a-3b1f-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
50090-4614-12023-01-30C16284748780-1f386c64a-3b1f-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
50090-4614-22023-01-30C16284748780-1f386c64a-3b1f-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
50090-4614-0Topiramate60 in 1 BOTTLETABLET6010
50090-4614-1Topiramate90 in 1 BOTTLETABLET9010
50090-4614-2Topiramate30 in 1 BOTTLETABLET3010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4614-0EA - Each50090-461495c56201-ef97-4e3a-91ea-d8936cb7653d12022-04-06
50090-4614-1EA - Each50090-46144c6ddaac-a6ff-40ba-973f-c620a282b42912022-12-07
50090-4614-2EA - Each50090-4614e6822714-4adb-41ce-a8b5-7bbfef0c07f612022-12-07

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199888topiramate 25 MG Oral TabletPSN7f1e4475-6326-47a3-a317-b04b74b7c10910
199888topiramate 25 MG Oral TabletSCD7f1e4475-6326-47a3-a317-b04b74b7c10910

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4614-05009046140060 TABLET in 1 BOTTLE (50090-4614-0) 60 tablet2019-10-160000-00-00NoNoCurrent
50090-4614-15009046140190 TABLET in 1 BOTTLE (50090-4614-1) 90 tablet2019-10-160000-00-00NoNoCurrent
50090-4614-25009046140230 TABLET in 1 BOTTLE (50090-4614-2) 30 tablet2019-10-160000-00-00NoNoCurrent