FDA.reportPublic FDA data

Topiramate

Product NDC
69097-123
11-digit product format
690970123
Labeler code
69097
Product ID
69097-123_71f493d9-3aaa-4b13-8057-012e96e11dbc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Topiramate
Dosage form
TABLET
Route
ORAL
Labeler
Cipla USA Inc.
Application
ANDA076343
Marketing category
ANDA
Marketing start
2014-06-12
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Topiramate
Listing expiration
2026-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69097-123-03Topiramate60 in 1 BOTTLETABLET6021
69097-123-12Topiramate500 in 1 BOTTLETABLET50021
69097-123-15Topiramate1000 in 1 BOTTLETABLET100021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-123-03EA - Each69097-123bc91dd47-b1ca-4617-8767-c14f50a222a012015-02-02
69097-123-12EA - Each69097-123394ec7e4-1429-4308-80ea-2767f7fa92fd12015-02-02
69097-123-15EA - Each69097-1235b442eb6-61f9-4a14-811b-8b8c37ed9fae12015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOPIRAMATEACTIVE INGREDIENT0H73WJJ391TOPIRAMATE TABLET [CIPLA USA INC.]5
TOPIRAMATEACTIVE MOIETY0H73WJJ391TOPIRAMATE TABLET [CIPLA USA INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTOPIRAMATE TABLET [CIPLA USA INC.]5
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKTOPIRAMATE TABLET [CIPLA USA INC.]5
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TOPIRAMATE TABLET [CIPLA USA INC.]5
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTOPIRAMATE TABLET [CIPLA USA INC.]5
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82TOPIRAMATE TABLET [CIPLA USA INC.]5
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6TOPIRAMATE TABLET [CIPLA USA INC.]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTOPIRAMATE TABLET [CIPLA USA INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TOPIRAMATE TABLET [CIPLA USA INC.]5
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQTOPIRAMATE TABLET [CIPLA USA INC.]5
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTOPIRAMATE TABLET [CIPLA USA INC.]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TOPIRAMATE TABLET [CIPLA USA INC.]5
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJTOPIRAMATE TABLET [CIPLA USA INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTOPIRAMATE TABLET [CIPLA USA INC.]5
TOPIRAMATEACTIVE INGREDIENT0H73WJJ391TOPIRAMATE TABLET, FILM COATED [DIRECTRX]1
TOPIRAMATEACTIVE MOIETY0H73WJJ391TOPIRAMATE TABLET, FILM COATED [DIRECTRX]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTOPIRAMATE TABLET, FILM COATED [DIRECTRX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTOPIRAMATE TABLET, FILM COATED [DIRECTRX]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TOPIRAMATE TABLET, FILM COATED [DIRECTRX]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TOPIRAMATE TABLET, FILM COATED [DIRECTRX]1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62TOPIRAMATE TABLET, FILM COATED [DIRECTRX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TOPIRAMATE TABLET, FILM COATED [DIRECTRX]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATOPIRAMATE TABLET, FILM COATED [DIRECTRX]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990TOPIRAMATE TABLET, FILM COATED [DIRECTRX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TOPIRAMATE TABLET, FILM COATED [DIRECTRX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTOPIRAMATE TABLET, FILM COATED [DIRECTRX]1
TALCINACTIVE INGREDIENT7SEV7J4R1UTOPIRAMATE TABLET, FILM COATED [DIRECTRX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTOPIRAMATE TABLET, FILM COATED [DIRECTRX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-123TOPIRAMATE TABLET [CIPLA USA INC.]19Current NDC, Legacy NDC, 3 package rows20230608_ca4ec248-285d-4066-8f89-5ed0c538c4c9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199889topiramate 100 MG Oral TabletPSNf16b14a2-297f-4adb-8d7a-5f43785faef726
151226topiramate 50 MG Oral TabletPSNf16b14a2-297f-4adb-8d7a-5f43785faef726
199889topiramate 100 MG Oral TabletSCDf16b14a2-297f-4adb-8d7a-5f43785faef726
151226topiramate 50 MG Oral TabletSCDf16b14a2-297f-4adb-8d7a-5f43785faef726
151226topiramate 50 MG Oral TabletPSNe39d2549-b489-426d-b576-741537e112e723
151226topiramate 50 MG Oral TabletSCDe39d2549-b489-426d-b576-741537e112e723
199889topiramate 100 MG Oral TabletPSNca4ec248-285d-4066-8f89-5ed0c538c4c921
199890topiramate 200 MG Oral TabletPSNca4ec248-285d-4066-8f89-5ed0c538c4c921
199888topiramate 25 MG Oral TabletPSNca4ec248-285d-4066-8f89-5ed0c538c4c921
151226topiramate 50 MG Oral TabletPSNca4ec248-285d-4066-8f89-5ed0c538c4c921
199889topiramate 100 MG Oral TabletSCDca4ec248-285d-4066-8f89-5ed0c538c4c921
199890topiramate 200 MG Oral TabletSCDca4ec248-285d-4066-8f89-5ed0c538c4c921
199888topiramate 25 MG Oral TabletSCDca4ec248-285d-4066-8f89-5ed0c538c4c921
151226topiramate 50 MG Oral TabletSCDca4ec248-285d-4066-8f89-5ed0c538c4c921
199890topiramate 200 MG Oral TabletPSN2082548c-371c-4c98-98a6-effe0a9bd2a46
151226topiramate 50 MG Oral TabletPSN2082548c-371c-4c98-98a6-effe0a9bd2a46
199890topiramate 200 MG Oral TabletSCD2082548c-371c-4c98-98a6-effe0a9bd2a46
151226topiramate 50 MG Oral TabletSCD2082548c-371c-4c98-98a6-effe0a9bd2a46
151226topiramate 50 MG Oral TabletPSNd8dff98f-185e-77ba-e053-2995a90aed2f5
151226topiramate 50 MG Oral TabletSCDd8dff98f-185e-77ba-e053-2995a90aed2f5
199888topiramate 25 MG Oral TabletPSN8a35067c-2f44-52b3-e053-2995a90a6bc14
151226topiramate 50 MG Oral TabletPSN8a35067c-2f44-52b3-e053-2995a90a6bc14
151226topiramate 50 MG Oral TabletPSNca45d478-7214-5bc7-e053-2995a90aa6014
199888topiramate 25 MG Oral TabletSCD8a35067c-2f44-52b3-e053-2995a90a6bc14
151226topiramate 50 MG Oral TabletSCD8a35067c-2f44-52b3-e053-2995a90a6bc14
151226topiramate 50 MG Oral TabletSCDca45d478-7214-5bc7-e053-2995a90aa6014
151226topiramate 50 MG Oral TabletPSN70a7a4bf-2f02-6deb-e053-2991aa0ae87f3
151226topiramate 50 MG Oral TabletPSNea0bcab1-cfe1-491c-875e-8c865449557e3
151226topiramate 50 MG Oral TabletPSN57ac12ed-27f0-4f5c-96ae-a7433714b4293
151226topiramate 50 MG Oral TabletSCD70a7a4bf-2f02-6deb-e053-2991aa0ae87f3
151226topiramate 50 MG Oral TabletSCD57ac12ed-27f0-4f5c-96ae-a7433714b4293
151226topiramate 50 MG Oral TabletSCDea0bcab1-cfe1-491c-875e-8c865449557e3
151226topiramate 50 MG Oral TabletPSN972c91c2-cfb4-e61d-e053-2a95a90a1b662
151226topiramate 50 MG Oral TabletPSNa578340b-0032-4cab-a57a-e1959829e6eb2
151226topiramate 50 MG Oral TabletSCD972c91c2-cfb4-e61d-e053-2a95a90a1b662
151226topiramate 50 MG Oral TabletSCDa578340b-0032-4cab-a57a-e1959829e6eb2
199889topiramate 100 MG Oral TabletPSN4e476c33-3590-4c6f-981d-915623cdacf01
199890topiramate 200 MG Oral TabletPSN4e476c33-3590-4c6f-981d-915623cdacf01
199888topiramate 25 MG Oral TabletPSN4e476c33-3590-4c6f-981d-915623cdacf01
151226topiramate 50 MG Oral TabletPSN4e476c33-3590-4c6f-981d-915623cdacf01
151226topiramate 50 MG Oral TabletPSN299cf1b6-67ca-46ad-913d-5f474ae7b8a01
151226topiramate 50 MG Oral TabletPSN71c6e31c-13dc-7f9c-e053-2a95a90ae7421
199889topiramate 100 MG Oral TabletSCD4e476c33-3590-4c6f-981d-915623cdacf01
199890topiramate 200 MG Oral TabletSCD4e476c33-3590-4c6f-981d-915623cdacf01
199888topiramate 25 MG Oral TabletSCD4e476c33-3590-4c6f-981d-915623cdacf01
151226topiramate 50 MG Oral TabletSCD4e476c33-3590-4c6f-981d-915623cdacf01
151226topiramate 50 MG Oral TabletSCD71c6e31c-13dc-7f9c-e053-2a95a90ae7421
151226topiramate 50 MG Oral TabletSCD299cf1b6-67ca-46ad-913d-5f474ae7b8a01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69097-123-036909701230360 TABLET in 1 BOTTLE (69097-123-03) 60 tablet2014-06-120000-00-00NoNoCurrent
69097-123-1269097012312500 TABLET in 1 BOTTLE (69097-123-12) 500 tablet2014-06-120000-00-00NoNoCurrent
69097-123-15690970123151000 TABLET in 1 BOTTLE (69097-123-15) 1000 tablet2014-06-120000-00-00NoNoCurrent