FDA.reportPublic FDA data

Topiramate

Product NDC
65862-172
11-digit product format
658620172
Labeler code
65862
Product ID
65862-172_67afee59-3d84-418f-832c-d00abd43fe5b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Topiramate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA078462
Marketing category
ANDA
Marketing start
2009-03-27
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
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
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
65862-172-05Topiramate500 in 1 BOTTLETABLET, FILM COATED50033
65862-172-60Topiramate60 in 1 BOTTLETABLET, FILM COATED6033
65862-172-99Topiramate1000 in 1 BOTTLETABLET, FILM COATED100033

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-172-60EA - Each65862-17245079abe-f932-4fec-bca7-1e862978a8fa12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOPIRAMATEACTIVE INGREDIENT0H73WJJ391TOPIRAMATE TABLET, FILM COATED TOPIRAMATE (TOPIRAMATE ) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
TOPIRAMATEACTIVE MOIETY0H73WJJ391TOPIRAMATE TABLET, FILM COATED TOPIRAMATE (TOPIRAMATE ) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTOPIRAMATE TABLET, FILM COATED TOPIRAMATE (TOPIRAMATE ) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TOPIRAMATE TABLET, FILM COATED TOPIRAMATE (TOPIRAMATE ) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTOPIRAMATE TABLET, FILM COATED TOPIRAMATE (TOPIRAMATE ) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82TOPIRAMATE TABLET, FILM COATED TOPIRAMATE (TOPIRAMATE ) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6TOPIRAMATE TABLET, FILM COATED TOPIRAMATE (TOPIRAMATE ) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTOPIRAMATE TABLET, FILM COATED TOPIRAMATE (TOPIRAMATE ) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TOPIRAMATE TABLET, FILM COATED TOPIRAMATE (TOPIRAMATE ) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQTOPIRAMATE TABLET, FILM COATED TOPIRAMATE (TOPIRAMATE ) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTOPIRAMATE TABLET, FILM COATED TOPIRAMATE (TOPIRAMATE ) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TOPIRAMATE TABLET, FILM COATED TOPIRAMATE (TOPIRAMATE ) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTOPIRAMATE TABLET, FILM COATED TOPIRAMATE (TOPIRAMATE ) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTOPIRAMATE TABLET, FILM COATED TOPIRAMATE (TOPIRAMATE ) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-172TOPIRAMATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]31Current NDC, Legacy NDC, 3 package rows20250508_32b48ea0-a215-43b8-83b4-a5435a686d68.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
151226topiramate 50 MG Oral TabletPSN4833f2e8-16b7-406f-937a-55bc978bf92c34
151226topiramate 50 MG Oral TabletSCD4833f2e8-16b7-406f-937a-55bc978bf92c34
199889topiramate 100 MG Oral TabletPSN32b48ea0-a215-43b8-83b4-a5435a686d6833
199890topiramate 200 MG Oral TabletPSN32b48ea0-a215-43b8-83b4-a5435a686d6833
199888topiramate 25 MG Oral TabletPSN32b48ea0-a215-43b8-83b4-a5435a686d6833
151226topiramate 50 MG Oral TabletPSN32b48ea0-a215-43b8-83b4-a5435a686d6833
199889topiramate 100 MG Oral TabletSCD32b48ea0-a215-43b8-83b4-a5435a686d6833
199890topiramate 200 MG Oral TabletSCD32b48ea0-a215-43b8-83b4-a5435a686d6833
199888topiramate 25 MG Oral TabletSCD32b48ea0-a215-43b8-83b4-a5435a686d6833
151226topiramate 50 MG Oral TabletSCD32b48ea0-a215-43b8-83b4-a5435a686d6833
199889topiramate 100 MG Oral TabletPSN444464fb-6a95-4e10-99a7-fdbc7dbb4c481
199888topiramate 25 MG Oral TabletPSN444464fb-6a95-4e10-99a7-fdbc7dbb4c481
151226topiramate 50 MG Oral TabletPSN444464fb-6a95-4e10-99a7-fdbc7dbb4c481
199889topiramate 100 MG Oral TabletSCD444464fb-6a95-4e10-99a7-fdbc7dbb4c481
199888topiramate 25 MG Oral TabletSCD444464fb-6a95-4e10-99a7-fdbc7dbb4c481
151226topiramate 50 MG Oral TabletSCD444464fb-6a95-4e10-99a7-fdbc7dbb4c481

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65862-172-0565862017205500 TABLET, FILM COATED in 1 BOTTLE (65862-172-05) 2022-04-110000-00-00NoNoCurrent
65862-172-606586201726060 TABLET, FILM COATED in 1 BOTTLE (65862-172-60) 2009-03-270000-00-00NoNoCurrent
65862-172-99658620172991000 TABLET, FILM COATED in 1 BOTTLE (65862-172-99) 2022-04-110000-00-00NoNoCurrent