FDA.reportPublic FDA data

TOPIRAMATE

Product NDC
61919-190
11-digit product format
619190190
Labeler code
61919
Product ID
61919-190_ee68f001-9190-42d6-800c-345ca900c220
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TOPIRAMATE
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA079162
Marketing category
ANDA
Marketing start
2015-01-01
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
E
Listing certified through
2017-12-31
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
61919-190-302020-01-31C16284748780-19d75b9d0-79d8-f424-e053-dadaa90a57ceTOPIRAMATE
61919-190-602020-01-31C16284748780-19d75b9d0-79d8-f424-e053-dadaa90a57ceTOPIRAMATE
61919-190-902020-01-31C16284748780-19d75b9d0-79d8-f424-e053-dadaa90a57ceTOPIRAMATE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-190-30TOPIRAMATE30 in 1 BOTTLETABLET306
61919-190-60TOPIRAMATE60 in 1 BOTTLETABLET606
61919-190-90TOPIRAMATE90 in 1 BOTTLETABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-190-30EA - Each61919-1906edc426e-cbd3-49d2-b0db-cfcbe1bac33e12015-11-12
61919-190-60EA - Each61919-1908ceb0bca-ccf8-4480-bc3b-2fec2895654012015-11-12
61919-190-90EA - Each61919-1905d44508c-d350-4429-8c1a-dd41e9e2465112015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOPIRAMATEACTIVE INGREDIENT0H73WJJ391TOPIRAMATE TABLET [DIRECT RX]6
TOPIRAMATEACTIVE MOIETY0H73WJJ391TOPIRAMATE TABLET [DIRECT RX]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTOPIRAMATE TABLET [DIRECT RX]6
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82TOPIRAMATE TABLET [DIRECT RX]6
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6TOPIRAMATE TABLET [DIRECT RX]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTOPIRAMATE TABLET [DIRECT RX]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TOPIRAMATE TABLET [DIRECT RX]6
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQTOPIRAMATE TABLET [DIRECT RX]6
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTOPIRAMATE TABLET [DIRECT RX]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TOPIRAMATE TABLET [DIRECT RX]6
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TOPIRAMATE TABLET [DIRECT RX]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTOPIRAMATE TABLET [DIRECT RX]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-190TOPIRAMATE TABLET [DIRECT RX]6Legacy NDC, 3 package rows20150917_b1ddad60-26ab-49a7-b8a9-96442dc0ac87.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199888topiramate 25 MG Oral TabletPSNb1ddad60-26ab-49a7-b8a9-96442dc0ac876
199888topiramate 25 MG Oral TabletSCDb1ddad60-26ab-49a7-b8a9-96442dc0ac876

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-190-306191901903030 in 1 BOTTLEHistorical
61919-190-606191901906060 in 1 BOTTLEHistorical
61919-190-906191901909090 in 1 BOTTLEHistorical