FDA.reportPublic FDA data

topiramate

Product NDC
29300-115
11-digit product format
293000115
Labeler code
29300
Product ID
29300-115_961973db-b7ab-40fa-ad75-4163738def9b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
topiramate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unichem Pharmaceuticals (USA), Inc.
Application
ANDA090162
Marketing category
ANDA
Marketing start
2013-07-01
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
29300-115-01topiramate100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10020
29300-115-05topiramate500 in 1 BOTTLE, PLASTICTABLET, FILM COATED50020
29300-115-10topiramate1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED100020
29300-115-16topiramate60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
29300-115-05EA - Each29300-115745e9958-67d3-4c55-98de-6bcce5312a0e12015-08-04
29300-115-10EA - Each29300-11598aa3c9d-bc55-4cec-bcfe-395b5a4f6a7b12015-08-04
29300-115-16EA - Each29300-115ae068afe-79bb-4eca-876d-82254dc1826912015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOPIRAMATEACTIVE INGREDIENT0H73WJJ391TOPIRAMATE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]5
TOPIRAMATEACTIVE MOIETY0H73WJJ391TOPIRAMATE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTOPIRAMATE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]5
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TOPIRAMATE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]5
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTOPIRAMATE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]5
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6TOPIRAMATE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTOPIRAMATE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TOPIRAMATE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]5
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WETOPIRAMATE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]5
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTOPIRAMATE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TOPIRAMATE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]5
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJTOPIRAMATE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTOPIRAMATE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29300-115TOPIRAMATE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]19Current NDC, Legacy NDC, 4 package rows20250416_6ee00e82-799d-445e-b658-a9712c49a28e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199888topiramate 25 MG Oral TabletPSN654f7c48-8c5d-4b97-88d6-397696f82b6a103
199888topiramate 25 MG Oral TabletSCD654f7c48-8c5d-4b97-88d6-397696f82b6a103
199888topiramate 25 MG Oral TabletPSN49701840-5a32-4ac1-8b07-5c61decacb95101
199888topiramate 25 MG Oral TabletSCD49701840-5a32-4ac1-8b07-5c61decacb95101
199889topiramate 100 MG Oral TabletPSNa5cffe7a-fdee-487a-bafb-a2d43e76c23c25
199888topiramate 25 MG Oral TabletPSNa5cffe7a-fdee-487a-bafb-a2d43e76c23c25
151226topiramate 50 MG Oral TabletPSNa5cffe7a-fdee-487a-bafb-a2d43e76c23c25
199889topiramate 100 MG Oral TabletSCDa5cffe7a-fdee-487a-bafb-a2d43e76c23c25
199888topiramate 25 MG Oral TabletSCDa5cffe7a-fdee-487a-bafb-a2d43e76c23c25
151226topiramate 50 MG Oral TabletSCDa5cffe7a-fdee-487a-bafb-a2d43e76c23c25
199889topiramate 100 MG Oral TabletPSN6ee00e82-799d-445e-b658-a9712c49a28e20
199890topiramate 200 MG Oral TabletPSN6ee00e82-799d-445e-b658-a9712c49a28e20
199888topiramate 25 MG Oral TabletPSN6ee00e82-799d-445e-b658-a9712c49a28e20
151226topiramate 50 MG Oral TabletPSN6ee00e82-799d-445e-b658-a9712c49a28e20
199889topiramate 100 MG Oral TabletSCD6ee00e82-799d-445e-b658-a9712c49a28e20
199890topiramate 200 MG Oral TabletSCD6ee00e82-799d-445e-b658-a9712c49a28e20
199888topiramate 25 MG Oral TabletSCD6ee00e82-799d-445e-b658-a9712c49a28e20
151226topiramate 50 MG Oral TabletSCD6ee00e82-799d-445e-b658-a9712c49a28e20
199888topiramate 25 MG Oral TabletPSNf66a529d-ba9d-4c8b-b58e-8fbcbcb8a11b5
151226topiramate 50 MG Oral TabletPSNf66a529d-ba9d-4c8b-b58e-8fbcbcb8a11b5
199888topiramate 25 MG Oral TabletSCDf66a529d-ba9d-4c8b-b58e-8fbcbcb8a11b5
151226topiramate 50 MG Oral TabletSCDf66a529d-ba9d-4c8b-b58e-8fbcbcb8a11b5
199888topiramate 25 MG Oral TabletPSNbe14624b-7eb9-4e7a-9274-1bb88270ecbe4
199888topiramate 25 MG Oral TabletSCDbe14624b-7eb9-4e7a-9274-1bb88270ecbe4
199888topiramate 25 MG Oral TabletPSNf781ada8-f90d-b233-e053-6394a90a87ff3
199888topiramate 25 MG Oral TabletSCDf781ada8-f90d-b233-e053-6394a90a87ff3
199888topiramate 25 MG Oral TabletPSN46a305cb-ab73-0bca-e063-6294a90a9b852
199888topiramate 25 MG Oral TabletPSN2d6d236b-9808-4e18-b521-e7435d1fd5cc2
199888topiramate 25 MG Oral TabletSCD46a305cb-ab73-0bca-e063-6294a90a9b852
199888topiramate 25 MG Oral TabletSCD2d6d236b-9808-4e18-b521-e7435d1fd5cc2
199888topiramate 25 MG Oral TabletPSN8706a35d-5c39-4daf-b83a-65f3d630e0431
199888topiramate 25 MG Oral TabletPSN52ba9c4f-e7d0-4352-e063-6394a90af7e21
199888topiramate 25 MG Oral TabletPSN521be3f1-3ee7-45c7-9f0c-17e08b6c8fca1
199888topiramate 25 MG Oral TabletPSN4b1d3130-cf3c-d7da-e063-6294a90a60791
199888topiramate 25 MG Oral TabletPSN1ef1c408-30f7-51ee-e063-6394a90ac8801
199888topiramate 25 MG Oral TabletSCD8706a35d-5c39-4daf-b83a-65f3d630e0431
199888topiramate 25 MG Oral TabletSCD52ba9c4f-e7d0-4352-e063-6394a90af7e21
199888topiramate 25 MG Oral TabletSCD521be3f1-3ee7-45c7-9f0c-17e08b6c8fca1
199888topiramate 25 MG Oral TabletSCD4b1d3130-cf3c-d7da-e063-6294a90a60791
199888topiramate 25 MG Oral TabletSCD1ef1c408-30f7-51ee-e063-6394a90ac8801

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
29300-115-0129300011501100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-115-01) 2013-07-010000-00-00NoNoCurrent
29300-115-0529300011505500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-115-05) 2013-07-010000-00-00NoNoCurrent
29300-115-10293000115101000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-115-10) 2013-07-010000-00-00NoNoCurrent
29300-115-162930001151660 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-115-16) 2013-07-010000-00-00NoNoCurrent