FDA.reportPublic FDA data

topiramate

Product NDC
68382-140
11-digit product format
683820140
Labeler code
68382
Product ID
68382-140_48ba6ac8-7f36-4a5c-8055-295af6083862
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
topiramate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA078235
Marketing category
ANDA
Marketing start
2009-03-27
Substance
TOPIRAMATE
Active strength
100 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
TOPIRAMATE100 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68382-140-01topiramate100 in 1 BOTTLETABLET, FILM COATED10028
68382-140-05topiramate500 in 1 BOTTLETABLET, FILM COATED50028
68382-140-14topiramate60 in 1 BOTTLETABLET, FILM COATED6028
68382-140-16topiramate90 in 1 BOTTLETABLET, FILM COATED9028

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-140-05EA - Each68382-140c77ad1cd-6864-4d18-9de3-bc0bf51dc25e12012-07-24
68382-140-14EA - Each68382-140367772e9-2ef9-4d5e-a4f6-d67584b93d8a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOPIRAMATEACTIVE INGREDIENT0H73WJJ391TOPIRAMATE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]11
TOPIRAMATEACTIVE MOIETY0H73WJJ391TOPIRAMATE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]11
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTOPIRAMATE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]11
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTOPIRAMATE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]11
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTOPIRAMATE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TOPIRAMATE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]11
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATOPIRAMATE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]11
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TOPIRAMATE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]11
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TOPIRAMATE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]11
TALCINACTIVE INGREDIENT7SEV7J4R1UTOPIRAMATE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]11
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTOPIRAMATE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]11
TOPIRAMATEACTIVE INGREDIENT0H73WJJ391TOPIRAMATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]9
TOPIRAMATEACTIVE MOIETY0H73WJJ391TOPIRAMATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]9
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTOPIRAMATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTOPIRAMATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]9
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTOPIRAMATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TOPIRAMATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]9
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATOPIRAMATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]9
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TOPIRAMATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]9
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TOPIRAMATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]9
TALCINACTIVE INGREDIENT7SEV7J4R1UTOPIRAMATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]9
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTOPIRAMATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-140TOPIRAMATE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.]26Current NDC, Legacy NDC, 4 package rows20250419_67dcdd6e-48bc-418e-a887-805929d83ce0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199889topiramate 100 MG Oral TabletPSNbffcd213-4f09-4a5b-8ccb-591a68be402b102
199889topiramate 100 MG Oral TabletSCDbffcd213-4f09-4a5b-8ccb-591a68be402b102
199889topiramate 100 MG Oral TabletPSN67dcdd6e-48bc-418e-a887-805929d83ce028
199890topiramate 200 MG Oral TabletPSN67dcdd6e-48bc-418e-a887-805929d83ce028
199888topiramate 25 MG Oral TabletPSN67dcdd6e-48bc-418e-a887-805929d83ce028
151226topiramate 50 MG Oral TabletPSN67dcdd6e-48bc-418e-a887-805929d83ce028
199889topiramate 100 MG Oral TabletSCD67dcdd6e-48bc-418e-a887-805929d83ce028
199890topiramate 200 MG Oral TabletSCD67dcdd6e-48bc-418e-a887-805929d83ce028
199888topiramate 25 MG Oral TabletSCD67dcdd6e-48bc-418e-a887-805929d83ce028
151226topiramate 50 MG Oral TabletSCD67dcdd6e-48bc-418e-a887-805929d83ce028
199889topiramate 100 MG Oral TabletPSN1af94c80-2b17-409a-98f6-ce00f942351d19
199889topiramate 100 MG Oral TabletPSN7e0834ee-920b-496f-954d-f9d81c3ba2d619
199890topiramate 200 MG Oral TabletPSN1af94c80-2b17-409a-98f6-ce00f942351d19
199888topiramate 25 MG Oral TabletPSN1af94c80-2b17-409a-98f6-ce00f942351d19
151226topiramate 50 MG Oral TabletPSN1af94c80-2b17-409a-98f6-ce00f942351d19
199889topiramate 100 MG Oral TabletSCD7e0834ee-920b-496f-954d-f9d81c3ba2d619
199889topiramate 100 MG Oral TabletSCD1af94c80-2b17-409a-98f6-ce00f942351d19
199890topiramate 200 MG Oral TabletSCD1af94c80-2b17-409a-98f6-ce00f942351d19
199888topiramate 25 MG Oral TabletSCD1af94c80-2b17-409a-98f6-ce00f942351d19
151226topiramate 50 MG Oral TabletSCD1af94c80-2b17-409a-98f6-ce00f942351d19
199889topiramate 100 MG Oral TabletPSNb7539f52-06e9-4663-b401-92f5f83653cc13
199889topiramate 100 MG Oral TabletSCDb7539f52-06e9-4663-b401-92f5f83653cc13
199889topiramate 100 MG Oral TabletPSN674c2c2e-014a-43a1-91a7-7214ffc4b1d710
199889topiramate 100 MG Oral TabletSCD674c2c2e-014a-43a1-91a7-7214ffc4b1d710
199889topiramate 100 MG Oral TabletPSNbe42ed09-350c-4e8a-aff4-6afb242dd5996
199889topiramate 100 MG Oral TabletSCDbe42ed09-350c-4e8a-aff4-6afb242dd5996
199889topiramate 100 MG Oral TabletPSN6fb00bd8-c49e-46ef-9d6b-1b602e1d11d85
199888topiramate 25 MG Oral TabletPSN6fb00bd8-c49e-46ef-9d6b-1b602e1d11d85
199889topiramate 100 MG Oral TabletSCD6fb00bd8-c49e-46ef-9d6b-1b602e1d11d85
199888topiramate 25 MG Oral TabletSCD6fb00bd8-c49e-46ef-9d6b-1b602e1d11d85
199889topiramate 100 MG Oral TabletPSN87dc077b-2c84-522b-e053-2995a90a68bc3
199889topiramate 100 MG Oral TabletPSNffd7be08-050e-dfcb-e053-6394a90ad2863
199889topiramate 100 MG Oral TabletSCDffd7be08-050e-dfcb-e053-6394a90ad2863
199889topiramate 100 MG Oral TabletSCD87dc077b-2c84-522b-e053-2995a90a68bc3
199889topiramate 100 MG Oral TabletPSNb8ded004-3fef-c5bf-e053-2995a90a9cc21
199889topiramate 100 MG Oral TabletPSN1a16d6a9-3dd1-ede8-e063-6294a90afe751
199889topiramate 100 MG Oral TabletSCDb8ded004-3fef-c5bf-e053-2995a90a9cc21
199889topiramate 100 MG Oral TabletSCD1a16d6a9-3dd1-ede8-e063-6294a90afe751

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68382-140-0168382014001100 TABLET, FILM COATED in 1 BOTTLE (68382-140-01) 2009-03-270000-00-00NoNoCurrent
68382-140-0568382014005500 TABLET, FILM COATED in 1 BOTTLE (68382-140-05) 2009-03-270000-00-00NoNoCurrent
68382-140-146838201401460 TABLET, FILM COATED in 1 BOTTLE (68382-140-14) 2009-03-270000-00-00NoNoCurrent
68382-140-166838201401690 TABLET, FILM COATED in 1 BOTTLE (68382-140-16) 2009-03-270000-00-00NoNoCurrent