FDA.reportPublic FDA data

Topiramate

Product NDC
47335-710
11-digit product format
473350710
Labeler code
47335
Product ID
47335-710_d4bed9ab-a090-49fe-a95e-5a7ce29c78ac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Topiramate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA090278
Marketing category
ANDA
Marketing start
2014-12-15
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47335-710-08Topiramate100 in 1 BOTTLETABLET, FILM COATED10022
47335-710-13Topiramate500 in 1 BOTTLETABLET, FILM COATED50022
47335-710-18Topiramate1000 in 1 BOTTLETABLET, FILM COATED100022
47335-710-83Topiramate30 in 1 BOTTLETABLET, FILM COATED3022
47335-710-86Topiramate60 in 1 BOTTLETABLET, FILM COATED6022
47335-710-88Topiramate100 in 1 BOTTLETABLET, FILM COATED10022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47335-710-13EA - Each47335-71082c32886-ef4d-4df4-8bd4-34d2236a969212015-03-03
47335-710-86EA - Each47335-710b3f87f6e-3398-4d0d-ac9d-2798deca99f112015-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOPIRAMATEACTIVE INGREDIENT0H73WJJ391TOPIRAMATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]6
TOPIRAMATEACTIVE MOIETY0H73WJJ391TOPIRAMATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]6
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTOPIRAMATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTOPIRAMATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]6
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTOPIRAMATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]6
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TOPIRAMATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]6
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTOPIRAMATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]6
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TOPIRAMATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]6
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62TOPIRAMATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TOPIRAMATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]6
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATOPIRAMATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]6
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990TOPIRAMATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]6
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TOPIRAMATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTOPIRAMATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]6
TALCINACTIVE INGREDIENT7SEV7J4R1UTOPIRAMATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTOPIRAMATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]6
TOPIRAMATEACTIVE INGREDIENT0H73WJJ391TOPIRAMATE TABLET TOPIRAMATE TABLET [APOTHECA, INC]1
TOPIRAMATEACTIVE MOIETY0H73WJJ391TOPIRAMATE TABLET TOPIRAMATE TABLET [APOTHECA, INC]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTOPIRAMATE TABLET TOPIRAMATE TABLET [APOTHECA, INC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTOPIRAMATE TABLET TOPIRAMATE TABLET [APOTHECA, INC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TOPIRAMATE TABLET TOPIRAMATE TABLET [APOTHECA, INC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATOPIRAMATE TABLET TOPIRAMATE TABLET [APOTHECA, INC]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990TOPIRAMATE TABLET TOPIRAMATE TABLET [APOTHECA, INC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TOPIRAMATE TABLET TOPIRAMATE TABLET [APOTHECA, INC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTOPIRAMATE TABLET TOPIRAMATE TABLET [APOTHECA, INC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UTOPIRAMATE TABLET TOPIRAMATE TABLET [APOTHECA, INC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTOPIRAMATE TABLET TOPIRAMATE TABLET [APOTHECA, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47335-710TOPIRAMATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]20Current NDC, Legacy NDC, 6 package rows20231229_3c909a53-ae66-4b28-a741-b60bb25a69cf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
151226topiramate 50 MG Oral TabletPSNffaacad8-4594-45a8-b292-02a84cd0c35b105
151226topiramate 50 MG Oral TabletSCDffaacad8-4594-45a8-b292-02a84cd0c35b105
151226topiramate 50 MG Oral TabletPSN1b847969-2124-4350-94b0-ef5ba707673b24
151226topiramate 50 MG Oral TabletSCD1b847969-2124-4350-94b0-ef5ba707673b24
151226topiramate 50 MG Oral TabletPSN6f2dcfd9-b4c2-4c06-abe5-8616632e525f6
151226topiramate 50 MG Oral TabletSCD6f2dcfd9-b4c2-4c06-abe5-8616632e525f6
151226topiramate 50 MG Oral TabletPSN3ac13777-45fb-45c2-84b8-d56aad7961404
151226topiramate 50 MG Oral TabletSCD3ac13777-45fb-45c2-84b8-d56aad7961404
151226topiramate 50 MG Oral TabletPSN9ddb8451-a455-87ec-e053-2995a90a5e5e3
151226topiramate 50 MG Oral TabletSCD9ddb8451-a455-87ec-e053-2995a90a5e5e3
151226topiramate 50 MG Oral TabletPSN8bd03bb2-3b9b-4707-a9a4-5618ddc3832f1
151226topiramate 50 MG Oral TabletSCD8bd03bb2-3b9b-4707-a9a4-5618ddc3832f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
47335-710-0847335071008100 TABLET, FILM COATED in 1 BOTTLE (47335-710-08) 2014-12-150000-00-00NoNoCurrent
47335-710-1347335071013500 TABLET, FILM COATED in 1 BOTTLE (47335-710-13) 2014-12-150000-00-00NoNoCurrent
47335-710-18473350710181000 TABLET, FILM COATED in 1 BOTTLE (47335-710-18) 2014-12-150000-00-00NoNoCurrent
47335-710-834733507108330 TABLET, FILM COATED in 1 BOTTLE (47335-710-83) 2014-12-150000-00-00NoNoCurrent
47335-710-864733507108660 TABLET, FILM COATED in 1 BOTTLE (47335-710-86) 2014-12-150000-00-00NoNoCurrent
47335-710-8847335071088100 TABLET, FILM COATED in 1 BOTTLE (47335-710-88) 2014-12-150000-00-00NoNoCurrent