FDA.reportPublic FDA data

Topiramate

Product NDC
68387-559
11-digit product format
683870559
Labeler code
68387
Product ID
68387-559_f66fe0dd-f036-43c8-8527-c1384dbd6791
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TOPIRAMATE
Dosage form
TABLET
Route
ORAL
Labeler
Keltman Pharmaceuticals Inc.
Application
ANDA079162
Marketing category
ANDA
Marketing start
2010-07-30
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
68387-559-302019-10-29C16284748780-1960f7f55-d607-8e05-e053-dbdaa90a074aTopiramate
68387-559-602019-10-29C16284748780-1960f7f55-d607-8e05-e053-dbdaa90a074aTopiramate
68387-559-902019-10-29C16284748780-1960f7f55-d607-8e05-e053-dbdaa90a074aTopiramate

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68387-559-30Topiramate30 in 1 BOTTLE, PLASTICTABLET301
68387-559-60Topiramate60 in 1 BOTTLE, PLASTICTABLET601
68387-559-90Topiramate90 in 1 BOTTLE, PLASTICTABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68387-559-30EA - Each68387-559e1e46e41-f621-4615-9f74-095880450cdd12012-07-24
68387-559-60EA - Each68387-559ae6d9f1a-18e4-4548-b29d-5ca361aa9e0a12012-07-24
68387-559-90EA - Each68387-559ec8d2b25-97ab-408c-8450-537e6434a6bc12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOPIRAMATEACTIVE INGREDIENT0H73WJJ391TOPIRAMATE TABLET [KELTMAN PHARMACEUTICALS INC.]1
TopiramateACTIVE MOIETY0H73WJJ391TOPIRAMATE TABLET [KELTMAN PHARMACEUTICALS INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTOPIRAMATE TABLET [KELTMAN PHARMACEUTICALS INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTOPIRAMATE TABLET [KELTMAN PHARMACEUTICALS INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TOPIRAMATE TABLET [KELTMAN PHARMACEUTICALS INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TOPIRAMATE TABLET [KELTMAN PHARMACEUTICALS INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTOPIRAMATE TABLET [KELTMAN PHARMACEUTICALS INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68387-559TOPIRAMATE TABLET [KELTMAN PHARMACEUTICALS INC.]1Legacy NDC, 3 package rows20110223_47fd4c44-56fa-4864-af5d-7b65c7b746d7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199889topiramate 100 MG Oral TabletPSN47fd4c44-56fa-4864-af5d-7b65c7b746d71
199890topiramate 200 MG Oral TabletPSN47fd4c44-56fa-4864-af5d-7b65c7b746d71
199888topiramate 25 MG Oral TabletPSN47fd4c44-56fa-4864-af5d-7b65c7b746d71
199889topiramate 100 MG Oral TabletSCD47fd4c44-56fa-4864-af5d-7b65c7b746d71
199890topiramate 200 MG Oral TabletSCD47fd4c44-56fa-4864-af5d-7b65c7b746d71
199888topiramate 25 MG Oral TabletSCD47fd4c44-56fa-4864-af5d-7b65c7b746d71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68387-559-306838705593030 in 1 BOTTLE, PLASTICHistorical
68387-559-606838705596060 in 1 BOTTLE, PLASTICHistorical
68387-559-906838705599090 in 1 BOTTLE, PLASTICHistorical