FDA.reportPublic FDA data

TOPIRAMATE

Product NDC
61919-825
11-digit product format
619190825
Labeler code
61919
Product ID
61919-825_9cad467c-4922-723b-e053-2a95a90ab82b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TOPIRAMATE
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA079153
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
0000-00-00
Substance
TOPIRAMATE
Active strength
50 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
2021-12-31
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
61919-825-302023-01-30C16284748780-1f386c649-f31b-0266-e053-dadaa90a7c1aTOPIRAMATE
61919-825-602023-01-30C16284748780-1f386c649-f31b-0266-e053-dadaa90a7c1aTOPIRAMATE
61919-825-902023-01-30C16284748780-1f386c649-f31b-0266-e053-dadaa90a7c1aTOPIRAMATE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-825-30TOPIRAMATE30 in 1 BOTTLETABLET305
61919-825-60TOPIRAMATE60 in 1 BOTTLETABLET605
61919-825-90TOPIRAMATE90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-825-30EA - Each61919-825f3fa7ab1-6051-4aac-b6dd-a3701d26093012015-12-02
61919-825-60EA - Each61919-8257244437a-9d5a-4e1d-b7c6-28e5b5b8664e12014-07-02
61919-825-90EA - Each61919-825210a4867-5f7a-4eca-8790-fdc315f48f5a12015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOPIRAMATEACTIVE INGREDIENT0H73WJJ391TOPIRAMATE TABLET [DIRECT RX]3
TOPIRAMATEACTIVE MOIETY0H73WJJ391TOPIRAMATE TABLET [DIRECT RX]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTOPIRAMATE TABLET [DIRECT RX]3
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TOPIRAMATE TABLET [DIRECT RX]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTOPIRAMATE TABLET [DIRECT RX]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTOPIRAMATE TABLET [DIRECT RX]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTOPIRAMATE TABLET [DIRECT RX]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TOPIRAMATE TABLET [DIRECT RX]3
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQTOPIRAMATE TABLET [DIRECT RX]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TOPIRAMATE TABLET [DIRECT RX]3
TALCINACTIVE INGREDIENT7SEV7J4R1UTOPIRAMATE TABLET [DIRECT RX]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTOPIRAMATE TABLET [DIRECT RX]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-825TOPIRAMATE TABLET [DIRECT RX]5Legacy NDC, 3 package rows20200131_44db00eb-4ec7-47f9-82c9-4bb767f5ba3f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
151226topiramate 50 MG Oral TabletPSN44db00eb-4ec7-47f9-82c9-4bb767f5ba3f5
151226topiramate 50 MG Oral TabletSCD44db00eb-4ec7-47f9-82c9-4bb767f5ba3f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-825-306191908253030 TABLET in 1 BOTTLE (61919-825-30) 30 tablet2014-01-010000-00-00NoNoCurrent
61919-825-606191908256060 TABLET in 1 BOTTLE (61919-825-60) 60 tablet2014-01-010000-00-00NoNoCurrent
61919-825-906191908259090 TABLET in 1 BOTTLE (61919-825-90) 90 tablet2014-01-010000-00-00NoNoCurrent