TOPIRAMATE

Product NDC
61919-185
11-digit product format
619190185
Labeler code
61919
Product ID
61919-185_f8495948-ec6f-49ad-8385-f3a79b64403e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
topiramate tablet
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA079153
Marketing category
ANDA
Marketing start
2015-01-01
Marketing end
0000-00-00
Substance
TOPIRAMATE
Active strength
100 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-185-302020-01-31C16284748780-19d75b9cf-ef09-f424-e053-dadaa90a57ceTOPIRAMATE- topiramate tablet
61919-185-602020-01-31C16284748780-19d75b9cf-ef09-f424-e053-dadaa90a57ceTOPIRAMATE- topiramate tablet

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-185-30TOPIRAMATE30 in 1 BOTTLETABLET301
61919-185-60TOPIRAMATE60 in 1 BOTTLETABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-185-30EA - Each61919-185c6cf96c7-5356-47a4-bd3c-43901e43027112016-09-02
61919-185-60EA - Each61919-185ecbcaa8c-9f0b-4e54-a5ed-403d43cd484a12016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOPIRAMATEACTIVE INGREDIENT0H73WJJ391TOPIRAMATE (TOPIRAMATE TABLET) TABLET [DIRECT RX]1
TOPIRAMATEACTIVE MOIETY0H73WJJ391TOPIRAMATE (TOPIRAMATE TABLET) TABLET [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTOPIRAMATE (TOPIRAMATE TABLET) TABLET [DIRECT RX]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TOPIRAMATE (TOPIRAMATE TABLET) TABLET [DIRECT RX]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTOPIRAMATE (TOPIRAMATE TABLET) TABLET [DIRECT RX]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTOPIRAMATE (TOPIRAMATE TABLET) TABLET [DIRECT RX]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTOPIRAMATE (TOPIRAMATE TABLET) TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TOPIRAMATE (TOPIRAMATE TABLET) TABLET [DIRECT RX]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQTOPIRAMATE (TOPIRAMATE TABLET) TABLET [DIRECT RX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TOPIRAMATE (TOPIRAMATE TABLET) TABLET [DIRECT RX]1
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJTOPIRAMATE (TOPIRAMATE TABLET) TABLET [DIRECT RX]1
TALCINACTIVE INGREDIENT7SEV7J4R1UTOPIRAMATE (TOPIRAMATE TABLET) TABLET [DIRECT RX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTOPIRAMATE (TOPIRAMATE TABLET) TABLET [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-185TOPIRAMATE (TOPIRAMATE TABLET) TABLET [DIRECT RX]1Legacy NDC, 2 package rows20150626_0f686676-8d66-4f29-966c-0a31e2eee90c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199889topiramate 100 MG Oral TabletPSN0f686676-8d66-4f29-966c-0a31e2eee90c1
199889topiramate 100 MG Oral TabletSCD0f686676-8d66-4f29-966c-0a31e2eee90c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-185-306191901853030 in 1 BOTTLEHistorical
61919-185-606191901856060 in 1 BOTTLEHistorical