FDA.reportPublic FDA data

topiramate

Product NDC
68382-139
11-digit product format
683820139
Labeler code
68382
Product ID
68382-139_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
50 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
TOPIRAMATE50 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
68382-139-01topiramate100 in 1 BOTTLETABLET, FILM COATED10028
68382-139-05topiramate500 in 1 BOTTLETABLET, FILM COATED50028
68382-139-14topiramate60 in 1 BOTTLETABLET, FILM COATED6028
68382-139-16topiramate90 in 1 BOTTLETABLET, FILM COATED9028

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-139-05EA - Each68382-139fbb3a5ad-4c8e-447a-8f15-57908b3d600f12012-07-24
68382-139-14EA - Each68382-1390455d17a-8b72-4d80-9ce3-e3690e806bb712012-07-24

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
68382-139TOPIRAMATE 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
151226topiramate 50 MG Oral TabletPSNca9ce6c1-5a60-467a-9ad5-acc7a9f8ca15103
151226topiramate 50 MG Oral TabletSCDca9ce6c1-5a60-467a-9ad5-acc7a9f8ca15103
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
151226topiramate 50 MG Oral TabletPSN6f461f84-bfad-44fa-a2bd-5ea1566444b521
151226topiramate 50 MG Oral TabletSCD6f461f84-bfad-44fa-a2bd-5ea1566444b521
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 TabletPSN2f5b1b0b-fd8a-4c4e-a85a-519ca841a0db19
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 TabletSCD2f5b1b0b-fd8a-4c4e-a85a-519ca841a0db19
151226topiramate 50 MG Oral TabletSCD1af94c80-2b17-409a-98f6-ce00f942351d19
151226topiramate 50 MG Oral TabletPSN83558f89-1adb-4d81-b19b-68721d48034b7
151226topiramate 50 MG Oral TabletSCD83558f89-1adb-4d81-b19b-68721d48034b7
151226topiramate 50 MG Oral TabletPSNb353e7fb-b976-96d8-e053-2995a90a110a6
151226topiramate 50 MG Oral TabletPSN92637f92-9d7c-c246-e053-2995a90a03476
151226topiramate 50 MG Oral TabletSCD92637f92-9d7c-c246-e053-2995a90a03476
151226topiramate 50 MG Oral TabletSCDb353e7fb-b976-96d8-e053-2995a90a110a6
151226topiramate 50 MG Oral TabletPSN033a2eb1-aba2-410b-8b9e-fafbc789ffa34
151226topiramate 50 MG Oral TabletSCD033a2eb1-aba2-410b-8b9e-fafbc789ffa34
151226topiramate 50 MG Oral TabletPSN813cc96c-5598-1ffd-e053-2991aa0ae9bd3
151226topiramate 50 MG Oral TabletPSNf3321dc5-0fb7-0d12-e053-2a95a90a96943
151226topiramate 50 MG Oral TabletSCD813cc96c-5598-1ffd-e053-2991aa0ae9bd3
151226topiramate 50 MG Oral TabletSCDf3321dc5-0fb7-0d12-e053-2a95a90a96943
151226topiramate 50 MG Oral TabletPSN9aefa085-6b91-445b-e053-2a95a90ae79f1
151226topiramate 50 MG Oral TabletPSNacafcdc0-9374-778f-e053-2a95a90a42621
151226topiramate 50 MG Oral TabletSCDacafcdc0-9374-778f-e053-2a95a90a42621
151226topiramate 50 MG Oral TabletSCD9aefa085-6b91-445b-e053-2a95a90ae79f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68382-139-0168382013901100 TABLET, FILM COATED in 1 BOTTLE (68382-139-01) 2009-03-270000-00-00NoNoCurrent
68382-139-0568382013905500 TABLET, FILM COATED in 1 BOTTLE (68382-139-05) 2009-03-270000-00-00NoNoCurrent
68382-139-146838201391460 TABLET, FILM COATED in 1 BOTTLE (68382-139-14) 2009-03-270000-00-00NoNoCurrent
68382-139-166838201391690 TABLET, FILM COATED in 1 BOTTLE (68382-139-16) 2009-03-270000-00-00NoNoCurrent