FDA.reportPublic FDA data

Topiramate

Product NDC
68462-110
11-digit product format
684620110
Labeler code
68462
Product ID
68462-110_c6569dc4-2be9-48f4-8e03-6da27ac996b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Topiramate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA077627
Marketing category
ANDA
Marketing start
2009-03-27
Substance
TOPIRAMATE
Active strength
200 mg/1
Pharmacologic classes
Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Topiramate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOPIRAMATE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0H73WJJ391
Rxcui151226, 199888, 199889, 199890

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68462-110-05Topiramate500 in 1 BOTTLETABLET, FILM COATED50026
68462-110-10Topiramate1000 in 1 BOTTLETABLET, FILM COATED100026
68462-110-60Topiramate60 in 1 BOTTLETABLET, FILM COATED6026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-110-10EA - Each68462-11093bedc7c-eeef-4b80-9096-116a0de42e6c12012-07-24
68462-110-60EA - Each68462-110c11b20f0-5e22-4c24-baed-bb3aaf7c40db12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOPIRAMATEACTIVE INGREDIENT0H73WJJ391TOPIRAMATE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]11
TOPIRAMATEACTIVE MOIETY0H73WJJ391TOPIRAMATE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]11
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTOPIRAMATE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]11
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8TOPIRAMATE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]11
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TOPIRAMATE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]11
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTOPIRAMATE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]11
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTOPIRAMATE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]11
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTOPIRAMATE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TOPIRAMATE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]11
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATOPIRAMATE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]11
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTOPIRAMATE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]11
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TOPIRAMATE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]11
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTOPIRAMATE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]11
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTOPIRAMATE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]11
WATERINACTIVE INGREDIENT059QF0KO0RTOPIRAMATE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-110TOPIRAMATE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]24Current NDC, Legacy NDC, 3 package rows20250503_35312f49-decf-428d-bf5f-4215b762ed3c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199889topiramate 100 MG Oral TabletPSN35312f49-decf-428d-bf5f-4215b762ed3c26
199890topiramate 200 MG Oral TabletPSN35312f49-decf-428d-bf5f-4215b762ed3c26
199888topiramate 25 MG Oral TabletPSN35312f49-decf-428d-bf5f-4215b762ed3c26
151226topiramate 50 MG Oral TabletPSN35312f49-decf-428d-bf5f-4215b762ed3c26
199889topiramate 100 MG Oral TabletSCD35312f49-decf-428d-bf5f-4215b762ed3c26
199890topiramate 200 MG Oral TabletSCD35312f49-decf-428d-bf5f-4215b762ed3c26
199888topiramate 25 MG Oral TabletSCD35312f49-decf-428d-bf5f-4215b762ed3c26
151226topiramate 50 MG Oral TabletSCD35312f49-decf-428d-bf5f-4215b762ed3c26

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68462-110-0568462011005500 TABLET, FILM COATED in 1 BOTTLE (68462-110-05) 2020-07-300000-00-00NoNoCurrent
68462-110-10684620110101000 TABLET, FILM COATED in 1 BOTTLE (68462-110-10) 2009-03-270000-00-00NoNoCurrent
68462-110-606846201106060 TABLET, FILM COATED in 1 BOTTLE (68462-110-60) 2009-03-270000-00-00NoNoCurrent