FDA.reportPublic FDA data

Topiramate

Product NDC
69097-125
11-digit product format
690970125
Labeler code
69097
Product ID
69097-125_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
200 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

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
69097-125-03Topiramate60 in 1 BOTTLETABLET6021
69097-125-12Topiramate500 in 1 BOTTLETABLET50021
69097-125-15Topiramate1000 in 1 BOTTLETABLET100021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-125-03EA - Each69097-125ab5cf59e-dde0-4252-93f8-831e3c511c5812015-02-02
69097-125-12EA - Each69097-125b485c1d1-ff74-4f21-9669-fe9af152d4fc12015-02-02
69097-125-15EA - Each69097-125b58817cf-4a76-4746-bf76-1c71682c38b112015-02-02

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
69097-125TOPIRAMATE 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
199890topiramate 200 MG Oral TabletPSNe9cb3c29-098c-405f-a200-b436ac7fa1a225
199890topiramate 200 MG Oral TabletSCDe9cb3c29-098c-405f-a200-b436ac7fa1a225
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 TabletPSNb71c09c5-43dd-4d98-9ab6-0b0c99908cac11
199890topiramate 200 MG Oral TabletSCDb71c09c5-43dd-4d98-9ab6-0b0c99908cac11
199890topiramate 200 MG Oral TabletPSNefc0d85e-fddc-4122-85b2-da2d2cb2f9d83
199890topiramate 200 MG Oral TabletSCDefc0d85e-fddc-4122-85b2-da2d2cb2f9d83
199889topiramate 100 MG Oral TabletPSN4e476c33-3590-4c6f-981d-915623cdacf01
199890topiramate 200 MG Oral TabletPSNe9be945a-7c08-3253-e053-2995a90abab41
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 TabletSCD4e476c33-3590-4c6f-981d-915623cdacf01
199890topiramate 200 MG Oral TabletSCDe9be945a-7c08-3253-e053-2995a90abab41
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
69097-125-036909701250360 TABLET in 1 BOTTLE (69097-125-03) 60 tablet2014-06-120000-00-00NoNoCurrent
69097-125-1269097012512500 TABLET in 1 BOTTLE (69097-125-12) 500 tablet2014-06-120000-00-00NoNoCurrent
69097-125-15690970125151000 TABLET in 1 BOTTLE (69097-125-15) 1000 tablet2014-06-120000-00-00NoNoCurrent