FDA.reportPublic FDA data

Topiramate

Product NDC
47335-711
11-digit product format
473350711
Labeler code
47335
Product ID
47335-711_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
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
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
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
47335-711-08Topiramate100 in 1 BOTTLETABLET, FILM COATED10022
47335-711-13Topiramate500 in 1 BOTTLETABLET, FILM COATED50022
47335-711-18Topiramate1000 in 1 BOTTLETABLET, FILM COATED100022
47335-711-83Topiramate30 in 1 BOTTLETABLET, FILM COATED3022
47335-711-86Topiramate60 in 1 BOTTLETABLET, FILM COATED6022
47335-711-88Topiramate100 in 1 BOTTLETABLET, FILM COATED10022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47335-711-13EA - Each47335-71171ed8043-c297-4803-b735-4b90d65fbb4312015-03-03
47335-711-86EA - Each47335-7110418c5d4-1b21-44aa-aa7b-c46aca322ba712015-03-03

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47335-711TOPIRAMATE 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
199889topiramate 100 MG Oral TabletPSNe846124d-e9e6-42c7-83f1-5df170d3f70b25
199889topiramate 100 MG Oral TabletSCDe846124d-e9e6-42c7-83f1-5df170d3f70b25
199889topiramate 100 MG Oral TabletPSN484c132f-3d3d-4218-b22f-82e9b56cc2f418
199889topiramate 100 MG Oral TabletSCD484c132f-3d3d-4218-b22f-82e9b56cc2f418
199889topiramate 100 MG Oral TabletPSN7d6752ce-7a56-4b04-ab15-cbd40aa5cc943
199889topiramate 100 MG Oral TabletPSN907c4230-257e-45fd-e053-2995a90a9a663
199889topiramate 100 MG Oral TabletSCD7d6752ce-7a56-4b04-ab15-cbd40aa5cc943
199889topiramate 100 MG Oral TabletSCD907c4230-257e-45fd-e053-2995a90a9a663
199889topiramate 100 MG Oral TabletPSN907a9929-4e0f-2f14-e053-2a95a90a244f2
199889topiramate 100 MG Oral TabletSCD907a9929-4e0f-2f14-e053-2a95a90a244f2
199889topiramate 100 MG Oral TabletPSN35bd4587-6e8a-13a1-e054-00144ff88e881
199889topiramate 100 MG Oral TabletSCD35bd4587-6e8a-13a1-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
47335-711-0847335071108100 TABLET, FILM COATED in 1 BOTTLE (47335-711-08) 2014-12-150000-00-00NoNoCurrent
47335-711-1347335071113500 TABLET, FILM COATED in 1 BOTTLE (47335-711-13) 2014-12-150000-00-00NoNoCurrent
47335-711-18473350711181000 TABLET, FILM COATED in 1 BOTTLE (47335-711-18) 2014-12-150000-00-00NoNoCurrent
47335-711-834733507118330 TABLET, FILM COATED in 1 BOTTLE (47335-711-83) 2014-12-150000-00-00NoNoCurrent
47335-711-864733507118660 TABLET, FILM COATED in 1 BOTTLE (47335-711-86) 2014-12-150000-00-00NoNoCurrent
47335-711-8847335071188100 TABLET, FILM COATED in 1 BOTTLE (47335-711-88) 2014-12-150000-00-00NoNoCurrent