FDA.reportPublic FDA data

Topiramate

Product NDC
63187-773
11-digit product format
631870773
Labeler code
63187
Product ID
63187-773_a3b868e4-d9b8-4e48-a11e-8bf67f9f4b52
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Topiramate
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
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
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
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
63187-773-302020-02-25C16284748780-19d75b9d0-c82c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TOPIRAMATE tablets, USP safely and effectively. See full prescribing information for TOPIRAMATE tablets, USP. TOPIRAMATE tablets USP, for oral Use. Initial U.S. Approval: 1996
63187-773-602020-02-25C16284748780-19d75b9d0-c82c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TOPIRAMATE tablets, USP safely and effectively. See full prescribing information for TOPIRAMATE tablets, USP. TOPIRAMATE tablets USP, for oral Use. Initial U.S. Approval: 1996
63187-773-902020-02-25C16284748780-19d75b9d0-c82c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TOPIRAMATE tablets, USP safely and effectively. See full prescribing information for TOPIRAMATE tablets, USP. TOPIRAMATE tablets USP, for oral Use. Initial U.S. Approval: 1996
63187-773-302020-01-31C16284748780-19d75b9d0-c82c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TOPIRAMATE tablets, USP safely and effectively. See full prescribing information for TOPIRAMATE tablets, USP. TOPIRAMATE tablets USP, for oral Use. Initial U.S. Approval: 1996
63187-773-602020-01-31C16284748780-19d75b9d0-c82c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TOPIRAMATE tablets, USP safely and effectively. See full prescribing information for TOPIRAMATE tablets, USP. TOPIRAMATE tablets USP, for oral Use. Initial U.S. Approval: 1996
63187-773-902020-01-31C16284748780-19d75b9d0-c82c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TOPIRAMATE tablets, USP safely and effectively. See full prescribing information for TOPIRAMATE tablets, USP. TOPIRAMATE tablets USP, for oral Use. Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-773-30Topiramate30 in 1 BOTTLETABLET304
63187-773-60Topiramate60 in 1 BOTTLETABLET604
63187-773-90Topiramate90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-773-30EA - Each63187-773221646a4-dd28-4e64-98b8-8f6e83720c1612017-04-05
63187-773-60EA - Each63187-7734befcecb-c97b-480a-a553-0764a4a5215312017-07-07
63187-773-90EA - Each63187-7733b797df7-5f2e-405b-9d5c-6555e70f009d12019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-773TOPIRAMATE TABLET [PROFICIENT RX LP]4Current NDC, Legacy NDC, 3 package rows20230702_2917ba32-3355-4d64-966a-8518e6fafdbe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199888topiramate 25 MG Oral TabletPSN2917ba32-3355-4d64-966a-8518e6fafdbe4
199888topiramate 25 MG Oral TabletSCD2917ba32-3355-4d64-966a-8518e6fafdbe4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-773-306318707733030 TABLET in 1 BOTTLE (63187-773-30) 30 tablet2016-11-010000-00-00NoNoCurrent
63187-773-606318707736060 TABLET in 1 BOTTLE (63187-773-60) 60 tablet2016-11-010000-00-00NoNoCurrent
63187-773-906318707739090 TABLET in 1 BOTTLE (63187-773-90) 90 tablet2016-11-010000-00-00NoNoCurrent