FDA.reportPublic FDA data

Topiramate

Product NDC
69097-124
11-digit product format
690970124
Labeler code
69097
Product ID
69097-124_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
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
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69097-124-03Topiramate60 in 1 BOTTLETABLET6021
69097-124-12Topiramate500 in 1 BOTTLETABLET50021
69097-124-15Topiramate1000 in 1 BOTTLETABLET100021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-124-03EA - Each69097-124835a5545-4dad-45f8-89a0-371f132adf7012015-02-02
69097-124-12EA - Each69097-124f624fc11-841a-4a49-a466-11430fc4c93912015-02-02
69097-124-15EA - Each69097-124418dc784-73c0-448a-8b47-36142d7272f912015-02-02

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-124TOPIRAMATE 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 TabletPSN78ef4e4e-d391-4417-952b-06202d5000d8102
199889topiramate 100 MG Oral TabletSCD78ef4e4e-d391-4417-952b-06202d5000d8102
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
199889topiramate 100 MG Oral TabletPSN9e516204-8f39-43c9-9f7e-d9777586f32122
199889topiramate 100 MG Oral TabletSCD9e516204-8f39-43c9-9f7e-d9777586f32122
199889topiramate 100 MG Oral TabletPSNca4ec248-285d-4066-8f89-5ed0c538c4c921
199889topiramate 100 MG Oral TabletPSN44095c2b-2e90-45d2-ab45-d0961c41550d21
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 TabletSCD44095c2b-2e90-45d2-ab45-d0961c41550d21
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
199889topiramate 100 MG Oral TabletPSN93da6674-14dc-4c8d-9424-03e4b2b4147920
199889topiramate 100 MG Oral TabletSCD93da6674-14dc-4c8d-9424-03e4b2b4147920
199889topiramate 100 MG Oral TabletPSNd63b64dd-b420-4283-9bac-92ba43c9f4295
199889topiramate 100 MG Oral TabletSCDd63b64dd-b420-4283-9bac-92ba43c9f4295
199889topiramate 100 MG Oral TabletPSN4a656a9f-8eb8-69b7-e054-00144ff8d46c4
199889topiramate 100 MG Oral TabletPSN164cb1f7-1a41-675f-e063-6294a90ae0dd4
199889topiramate 100 MG Oral TabletSCD4a656a9f-8eb8-69b7-e054-00144ff8d46c4
199889topiramate 100 MG Oral TabletSCD164cb1f7-1a41-675f-e063-6294a90ae0dd4
199889topiramate 100 MG Oral TabletPSN90a56683-88c8-3c75-e053-2a95a90a09462
199889topiramate 100 MG Oral TabletSCD90a56683-88c8-3c75-e053-2a95a90a09462
199889topiramate 100 MG Oral TabletPSN4e476c33-3590-4c6f-981d-915623cdacf01
199889topiramate 100 MG Oral TabletPSN1770f22c-9a80-4be5-ae77-9537ea25990f1
199889topiramate 100 MG Oral TabletPSN10a9e6fa-4d55-6b5c-e063-6294a90a608c1
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
199889topiramate 100 MG Oral TabletSCD10a9e6fa-4d55-6b5c-e063-6294a90a608c1
199889topiramate 100 MG Oral TabletSCD4e476c33-3590-4c6f-981d-915623cdacf01
199889topiramate 100 MG Oral TabletSCD1770f22c-9a80-4be5-ae77-9537ea25990f1
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69097-124-036909701240360 TABLET in 1 BOTTLE (69097-124-03) 60 tablet2014-06-120000-00-00NoNoCurrent
69097-124-1269097012412500 TABLET in 1 BOTTLE (69097-124-12) 500 tablet2014-06-120000-00-00NoNoCurrent
69097-124-15690970124151000 TABLET in 1 BOTTLE (69097-124-15) 1000 tablet2014-06-120000-00-00NoNoCurrent