FDA.reportPublic FDA data

TOPIRAMATE

Product NDC
61919-679
11-digit product format
619190679
Labeler code
61919
Product ID
61919-679_d61ccfc4-b17e-7066-e053-2995a90a6318
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TOPIRAMATE
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA076343
Marketing category
ANDA
Marketing start
2019-08-07
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

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
61919-679-722025-01-30C16284748780-12cef2736-a86a-d83d-e063-dadaa90ab31fTOPIRAMATE
61919-679-862025-01-30C16284748780-12cef2736-a86a-d83d-e063-dadaa90ab31fTOPIRAMATE
61919-679-302020-01-31C16284748780-19d75b9d0-e1be-f424-e053-dadaa90a57ceTOPIRAMATE
61919-679-602020-01-31C16284748780-19d75b9d0-e1be-f424-e053-dadaa90a57ceTOPIRAMATE
61919-679-902020-01-31C16284748780-19d75b9d0-e1be-f424-e053-dadaa90a57ceTOPIRAMATE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-679-72TOPIRAMATE120 in 1 BOTTLETABLET1204
61919-679-86TOPIRAMATE270 in 1 BOTTLETABLET2704
61919-679-30TOPIRAMATE30 in 1 BOTTLETABLET303
61919-679-60TOPIRAMATE60 in 1 BOTTLETABLET603
61919-679-90TOPIRAMATE90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-679-30EA - Each61919-6795360912d-9062-45c8-ac55-789e5ef7f4ee12016-10-06
61919-679-60EA - Each61919-679d2469208-c8f9-4f41-8ea2-a46ec739aa6512016-10-06
61919-679-72EA - Each61919-6793b21b5c2-57f7-41d2-b6c8-428a4f7ca04912019-09-05
61919-679-86EA - Each61919-679bc51e6f2-db7c-4cd7-872c-14f062b851e212024-01-04
61919-679-90EA - Each61919-67956e1ff86-f492-4bf1-b621-0662d987d24e12016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-679TOPIRAMATE TABLET [DIRECT_RX]4Legacy NDC, 2 package rows20231216_8f8bb1f7-74e4-31b5-e053-2995a90ae176.zip
61919-679TOPIRAMATE TABLET [DIRECT RX]3Legacy NDC, 3 package rows20161114_3d6b2a30-28c3-1735-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199888topiramate 25 MG Oral TabletPSN8f8bb1f7-74e4-31b5-e053-2995a90ae1764
199888topiramate 25 MG Oral TabletSCD8f8bb1f7-74e4-31b5-e053-2995a90ae1764
199888topiramate 25 MG Oral TabletPSN3d6b2a30-28c3-1735-e054-00144ff88e883
199888topiramate 25 MG Oral TabletSCD3d6b2a30-28c3-1735-e054-00144ff88e883

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-679-306191906793030 in 1 BOTTLEHistorical
61919-679-606191906796060 in 1 BOTTLEHistorical
61919-679-7261919067972120 TABLET in 1 BOTTLE (61919-679-72) 120 tablet2019-08-070000-00-00NoNoCurrent
61919-679-8661919067986270 in 1 BOTTLEHistorical
61919-679-906191906799090 in 1 BOTTLEHistorical