FDA.reportPublic FDA data

TOPIRAMATE

Product NDC
61919-883
11-digit product format
619190883
Labeler code
61919
Product ID
61919-883_b8ba0422-dd85-cd4f-e053-2995a90ad3f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TOPIRAMATE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Direct_Rx
Application
ANDA078235
Marketing category
ANDA
Marketing start
2019-05-31
Marketing end
0000-00-00
Substance
TOPIRAMATE
Active strength
25 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
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
61919-883-302025-01-30C16284748780-12cef2736-75af-d83d-e063-dadaa90ab31fTOPIRAMATE
61919-883-602025-01-30C16284748780-12cef2736-75af-d83d-e063-dadaa90ab31fTOPIRAMATE
61919-883-722025-01-30C16284748780-12cef2736-9f88-d83d-e063-dadaa90ab31fTOPIRAMATE
61919-883-862025-01-30C16284748780-12cef2736-75af-d83d-e063-dadaa90ab31fTOPIRAMATE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-883-30TOPIRAMATE30 in 1 BOTTLETABLET, FILM COATED304
61919-883-60TOPIRAMATE60 in 1 BOTTLETABLET, FILM COATED604
61919-883-86TOPIRAMATE270 in 1 BOTTLETABLET, FILM COATED2704
61919-883-72TOPIRAMATE120 in 1 BOTTLETABLET, FILM COATED1201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-883-30EA - Each61919-883cefb26e7-f896-4ea8-ad0b-6b96de71691e12019-07-02
61919-883-60EA - Each61919-883879bbe2f-f9fd-42ff-a86f-e283e6065ee312020-07-13
61919-883-72EA - Each61919-883264c2db8-89cb-461a-8728-303dff4c719312019-07-02
61919-883-86EA - Each61919-8834b9e9f03-cbe1-449d-b541-2dd4347c4ff112023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-883TOPIRAMATE TABLET, FILM COATED TOPIRAMATE TABLET [DIRECT_RX]4Legacy NDC, 3 package rows20230316_8a35067c-2f44-52b3-e053-2995a90a6bc1.zip
61919-883TOPIRAMATE TABLET, FILM COATED [DIRECT_RX]1Legacy NDC, 1 package rows20190601_8a2f8ea0-bf2c-09b1-e053-2a95a90a105c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199888topiramate 25 MG Oral TabletPSN8a35067c-2f44-52b3-e053-2995a90a6bc14
151226topiramate 50 MG Oral TabletPSN8a35067c-2f44-52b3-e053-2995a90a6bc14
199888topiramate 25 MG Oral TabletSCD8a35067c-2f44-52b3-e053-2995a90a6bc14
151226topiramate 50 MG Oral TabletSCD8a35067c-2f44-52b3-e053-2995a90a6bc14
199888topiramate 25 MG Oral TabletPSN8a2f8ea0-bf2c-09b1-e053-2a95a90a105c1
199888topiramate 25 MG Oral TabletSCD8a2f8ea0-bf2c-09b1-e053-2a95a90a105c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-883-306191908833030 TABLET, FILM COATED in 1 BOTTLE (61919-883-30) 2019-05-310000-00-00NoNoCurrent
61919-883-606191908836060 TABLET, FILM COATED in 1 BOTTLE (61919-883-60) 2019-05-310000-00-00NoNoCurrent
61919-883-7261919088372120 TABLET, FILM COATED in 1 BOTTLE (61919-883-72) 2019-05-310000-00-00NoNoCurrent
61919-883-8661919088386270 in 1 BOTTLEHistorical