FDA.reportPublic FDA data

Topiramate

Product NDC
69097-122
11-digit product format
690970122
Labeler code
69097
Product ID
69097-122_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
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
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
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
69097-122-03Topiramate60 in 1 BOTTLETABLET6021
69097-122-12Topiramate500 in 1 BOTTLETABLET50021
69097-122-15Topiramate1000 in 1 BOTTLETABLET100021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-122-03EA - Each69097-1226e5c0169-3ee5-4c7b-a547-4b92f292f29912015-02-02
69097-122-12EA - Each69097-122594c7c34-4734-46ea-9a83-693ed716907c12015-02-02
69097-122-15EA - Each69097-122b203fb82-dd95-42c0-88cb-46c6fee279ad12015-02-02

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
69097-122TOPIRAMATE 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
199888topiramate 25 MG Oral TabletPSN1f327383-beb3-4d15-add6-5f1c749f2b3f26
199888topiramate 25 MG Oral TabletSCD1f327383-beb3-4d15-add6-5f1c749f2b3f26
199889topiramate 100 MG Oral TabletPSNca4ec248-285d-4066-8f89-5ed0c538c4c921
199890topiramate 200 MG Oral TabletPSNca4ec248-285d-4066-8f89-5ed0c538c4c921
199888topiramate 25 MG Oral TabletPSN0cf388dc-d8f1-4478-bf5f-e64638ee580121
199888topiramate 25 MG Oral TabletPSN55e71f43-1cd5-4efc-9641-fda0a09c30f021
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
199888topiramate 25 MG Oral TabletSCD0cf388dc-d8f1-4478-bf5f-e64638ee580121
199888topiramate 25 MG Oral TabletSCD55e71f43-1cd5-4efc-9641-fda0a09c30f021
151226topiramate 50 MG Oral TabletSCDca4ec248-285d-4066-8f89-5ed0c538c4c921
199888topiramate 25 MG Oral TabletPSN7f1e4475-6326-47a3-a317-b04b74b7c10910
199888topiramate 25 MG Oral TabletSCD7f1e4475-6326-47a3-a317-b04b74b7c10910
199888topiramate 25 MG Oral TabletPSNc30881eb-809e-4cc5-9bec-f4eda4b01b569
199888topiramate 25 MG Oral TabletSCDc30881eb-809e-4cc5-9bec-f4eda4b01b569
199888topiramate 25 MG Oral TabletPSN490f109f-30cb-0790-e054-00144ff88e886
199888topiramate 25 MG Oral TabletSCD490f109f-30cb-0790-e054-00144ff88e886
199888topiramate 25 MG Oral TabletPSN8f8bb1f7-74e4-31b5-e053-2995a90ae1764
199888topiramate 25 MG Oral TabletPSN2917ba32-3355-4d64-966a-8518e6fafdbe4
199888topiramate 25 MG Oral TabletSCD8f8bb1f7-74e4-31b5-e053-2995a90ae1764
199888topiramate 25 MG Oral TabletSCD2917ba32-3355-4d64-966a-8518e6fafdbe4
199888topiramate 25 MG Oral TabletPSNeca774cf-2e4e-7642-e053-2a95a90a847d3
199888topiramate 25 MG Oral TabletPSN75d7173b-497e-d0eb-e053-2991aa0a7cb83
199888topiramate 25 MG Oral TabletPSN3d6b2a30-28c3-1735-e054-00144ff88e883
199888topiramate 25 MG Oral TabletSCD75d7173b-497e-d0eb-e053-2991aa0a7cb83
199888topiramate 25 MG Oral TabletSCDeca774cf-2e4e-7642-e053-2a95a90a847d3
199888topiramate 25 MG Oral TabletSCD3d6b2a30-28c3-1735-e054-00144ff88e883
199888topiramate 25 MG Oral TabletPSNd0f88baf-2462-4371-8543-996b9399004e2
199888topiramate 25 MG Oral TabletSCDd0f88baf-2462-4371-8543-996b9399004e2
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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69097-122-036909701220360 TABLET in 1 BOTTLE (69097-122-03) 60 tablet2014-06-120000-00-00NoNoCurrent
69097-122-1269097012212500 TABLET in 1 BOTTLE (69097-122-12) 500 tablet2014-06-120000-00-00NoNoCurrent
69097-122-15690970122151000 TABLET in 1 BOTTLE (69097-122-15) 1000 tablet2014-06-120000-00-00NoNoCurrent