FDA.reportPublic FDA data

topiramate

Product NDC
68382-138
11-digit product format
683820138
Labeler code
68382
Product ID
68382-138_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
25 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
TOPIRAMATE25 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
68382-138-01topiramate100 in 1 BOTTLETABLET, FILM COATED10028
68382-138-05topiramate500 in 1 BOTTLETABLET, FILM COATED50028
68382-138-14topiramate60 in 1 BOTTLETABLET, FILM COATED6028
68382-138-16topiramate90 in 1 BOTTLETABLET, FILM COATED9028

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-138-05EA - Each68382-1381d1548d1-73e7-49e2-b76c-0346c89ade1912012-07-24
68382-138-14EA - Each68382-138f0c073bf-1974-4278-9ea4-92be917215ce12012-07-24

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
TOPIRAMATEACTIVE INGREDIENT0H73WJJ391TOPIRAMATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TOPIRAMATEACTIVE MOIETY0H73WJJ391TOPIRAMATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTOPIRAMATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTOPIRAMATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TOPIRAMATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTOPIRAMATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TOPIRAMATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATOPIRAMATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TOPIRAMATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TALCINACTIVE INGREDIENT7SEV7J4R1UTOPIRAMATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTOPIRAMATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-138TOPIRAMATE 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 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
199888topiramate 25 MG Oral TabletPSN149d20de-f262-4567-aa97-d4d28a1653cb20
199888topiramate 25 MG Oral TabletSCD149d20de-f262-4567-aa97-d4d28a1653cb20
199889topiramate 100 MG Oral TabletPSN1af94c80-2b17-409a-98f6-ce00f942351d19
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 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
199888topiramate 25 MG Oral TabletPSN5ce65b7f-9215-47a8-a784-f87a810bd7e415
199888topiramate 25 MG Oral TabletSCD5ce65b7f-9215-47a8-a784-f87a810bd7e415
199888topiramate 25 MG Oral TabletPSN57462baf-2f32-4bde-9627-2214c8af93708
199888topiramate 25 MG Oral TabletSCD57462baf-2f32-4bde-9627-2214c8af93708
199888topiramate 25 MG Oral TabletPSNd8454fdf-7b34-49c0-b130-732e39b774b27
199888topiramate 25 MG Oral TabletSCDd8454fdf-7b34-49c0-b130-732e39b774b27
199889topiramate 100 MG Oral TabletPSN6fb00bd8-c49e-46ef-9d6b-1b602e1d11d85
199888topiramate 25 MG Oral TabletPSNf7f2d1bc-9c65-4798-826f-6902b3ec81dc5
199888topiramate 25 MG Oral TabletPSNafd4c2b9-b80c-b43a-e053-2995a90ac9235
199888topiramate 25 MG Oral TabletPSN6fb00bd8-c49e-46ef-9d6b-1b602e1d11d85
199889topiramate 100 MG Oral TabletSCD6fb00bd8-c49e-46ef-9d6b-1b602e1d11d85
199888topiramate 25 MG Oral TabletSCDf7f2d1bc-9c65-4798-826f-6902b3ec81dc5
199888topiramate 25 MG Oral TabletSCD6fb00bd8-c49e-46ef-9d6b-1b602e1d11d85
199888topiramate 25 MG Oral TabletSCDafd4c2b9-b80c-b43a-e053-2995a90ac9235
199888topiramate 25 MG Oral TabletPSN8a35067c-2f44-52b3-e053-2995a90a6bc14
199888topiramate 25 MG Oral TabletPSN9221403c-467f-738e-e053-2995a90ac8fd4
151226topiramate 50 MG Oral TabletPSN8a35067c-2f44-52b3-e053-2995a90a6bc14
199888topiramate 25 MG Oral TabletSCD8a35067c-2f44-52b3-e053-2995a90a6bc14
199888topiramate 25 MG Oral TabletSCD9221403c-467f-738e-e053-2995a90ac8fd4
151226topiramate 50 MG Oral TabletSCD8a35067c-2f44-52b3-e053-2995a90a6bc14
199888topiramate 25 MG Oral TabletPSN80481455-7ad7-4f44-8113-b8b61d8581a03
199888topiramate 25 MG Oral TabletSCD80481455-7ad7-4f44-8113-b8b61d8581a03
199888topiramate 25 MG Oral TabletPSNac9e0ef2-003a-63ae-e053-2a95a90a687d2
199888topiramate 25 MG Oral TabletPSN835e5fa5-c602-8787-e053-2991aa0a7ba52
199888topiramate 25 MG Oral TabletSCDac9e0ef2-003a-63ae-e053-2a95a90a687d2
199888topiramate 25 MG Oral TabletSCD835e5fa5-c602-8787-e053-2991aa0a7ba52
199888topiramate 25 MG Oral TabletPSNbdfb5130-eeb7-4cfd-9d68-b62ea1698a061
199888topiramate 25 MG Oral TabletPSN8a2f8ea0-bf2c-09b1-e053-2a95a90a105c1
199888topiramate 25 MG Oral TabletPSNe9f64563-284b-465c-9873-44c1d3edc94e1
199888topiramate 25 MG Oral TabletSCDbdfb5130-eeb7-4cfd-9d68-b62ea1698a061
199888topiramate 25 MG Oral TabletSCD8a2f8ea0-bf2c-09b1-e053-2a95a90a105c1
199888topiramate 25 MG Oral TabletSCDe9f64563-284b-465c-9873-44c1d3edc94e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68382-138-0168382013801100 TABLET, FILM COATED in 1 BOTTLE (68382-138-01) 2009-03-270000-00-00NoNoCurrent
68382-138-0568382013805500 TABLET, FILM COATED in 1 BOTTLE (68382-138-05) 2009-03-270000-00-00NoNoCurrent
68382-138-146838201381460 TABLET, FILM COATED in 1 BOTTLE (68382-138-14) 2009-03-270000-00-00NoNoCurrent
68382-138-166838201381690 TABLET, FILM COATED in 1 BOTTLE (68382-138-16) 2009-03-270000-00-00NoNoCurrent