FDA.reportPublic FDA data

TOPIRAMATE

Product NDC
61919-691
11-digit product format
619190691
Labeler code
61919
Product ID
61919-691_00ccf645-ff1d-45d0-83a5-69c69dc25456
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TOPIRAMATE
Dosage form
TABLET
Route
ORAL
Labeler
DirectRX
Application
ANDA079162
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-691-302020-01-31C16284748780-19d75b9d0-ff1f-f424-e053-dadaa90a57ceTOPIRAMATE
61919-691-602020-01-31C16284748780-19d75b9d0-ff1f-f424-e053-dadaa90a57ceTOPIRAMATE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-691-30TOPIRAMATE30 in 1 BOTTLETABLET301
61919-691-60TOPIRAMATE60 in 1 BOTTLETABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-691-30EA - Each61919-691df69c729-3321-46b9-b7fb-fdf001eaa65612016-09-02
61919-691-60EA - Each61919-6916e5ce0da-61e5-4700-b32f-c65f9151fa4d12016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOPIRAMATEACTIVE INGREDIENT0H73WJJ391TOPIRAMATE TABLET [DIRECTRX]1
TOPIRAMATEACTIVE MOIETY0H73WJJ391TOPIRAMATE TABLET [DIRECTRX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTOPIRAMATE TABLET [DIRECTRX]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TOPIRAMATE TABLET [DIRECTRX]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTOPIRAMATE TABLET [DIRECTRX]1
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82TOPIRAMATE TABLET [DIRECTRX]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6TOPIRAMATE TABLET [DIRECTRX]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTOPIRAMATE TABLET [DIRECTRX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TOPIRAMATE TABLET [DIRECTRX]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQTOPIRAMATE TABLET [DIRECTRX]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTOPIRAMATE TABLET [DIRECTRX]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TOPIRAMATE TABLET [DIRECTRX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TOPIRAMATE TABLET [DIRECTRX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTOPIRAMATE TABLET [DIRECTRX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-691TOPIRAMATE TABLET [DIRECTRX]1Legacy NDC, 2 package rows20151022_45f0fa04-6c5b-4097-a63a-bc9d08f1b743.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199889topiramate 100 MG Oral TabletPSN45f0fa04-6c5b-4097-a63a-bc9d08f1b7431
199889topiramate 100 MG Oral TabletSCD45f0fa04-6c5b-4097-a63a-bc9d08f1b7431

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-691-306191906913030 in 1 BOTTLEHistorical
61919-691-606191906916060 in 1 BOTTLEHistorical