FDA.reportPublic FDA data

Topiramate

Product NDC
63187-283
11-digit product format
631870283
Labeler code
63187
Product ID
63187-283_827436d3-2e3e-4a88-ab20-190eba38810a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Topiramate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA077627
Marketing category
ANDA
Marketing start
2009-03-27
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
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
TOPIRAMATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0H73WJJ391
Rxcui151226, 199889

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
63187-283-30Topiramate30 in 1 BOTTLETABLET, FILM COATED303
63187-283-60Topiramate60 in 1 BOTTLETABLET, FILM COATED603
63187-283-90Topiramate90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-283-60EA - Each63187-28345784145-3e92-4b82-a2d4-0ae71723290712016-10-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOPIRAMATEACTIVE INGREDIENT0H73WJJ391TOPIRAMATE TABLET, FILM COATED [PROFICIENT RX LP]1
TOPIRAMATEACTIVE MOIETY0H73WJJ391TOPIRAMATE TABLET, FILM COATED [PROFICIENT RX LP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTOPIRAMATE TABLET, FILM COATED [PROFICIENT RX LP]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8TOPIRAMATE TABLET, FILM COATED [PROFICIENT RX LP]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TOPIRAMATE TABLET, FILM COATED [PROFICIENT RX LP]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTOPIRAMATE TABLET, FILM COATED [PROFICIENT RX LP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTOPIRAMATE TABLET, FILM COATED [PROFICIENT RX LP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTOPIRAMATE TABLET, FILM COATED [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TOPIRAMATE TABLET, FILM COATED [PROFICIENT RX LP]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATOPIRAMATE TABLET, FILM COATED [PROFICIENT RX LP]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTOPIRAMATE TABLET, FILM COATED [PROFICIENT RX LP]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TOPIRAMATE TABLET, FILM COATED [PROFICIENT RX LP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTOPIRAMATE TABLET, FILM COATED [PROFICIENT RX LP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTOPIRAMATE TABLET, FILM COATED [PROFICIENT RX LP]1
WATERINACTIVE INGREDIENT059QF0KO0RTOPIRAMATE TABLET, FILM COATED [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-283TOPIRAMATE TABLET, FILM COATED [PROFICIENT RX LP]3Current NDC, Legacy NDC, 3 package rows20200923_5d9b2c1d-565e-4c43-96ef-e5cd2593d0a8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199889topiramate 100 MG Oral TabletPSN5d9b2c1d-565e-4c43-96ef-e5cd2593d0a83
151226topiramate 50 MG Oral TabletPSN5d9b2c1d-565e-4c43-96ef-e5cd2593d0a83
199889topiramate 100 MG Oral TabletSCD5d9b2c1d-565e-4c43-96ef-e5cd2593d0a83
151226topiramate 50 MG Oral TabletSCD5d9b2c1d-565e-4c43-96ef-e5cd2593d0a83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-283-306318702833030 TABLET, FILM COATED in 1 BOTTLE (63187-283-30) 2019-01-010000-00-00NoNoCurrent
63187-283-606318702836060 TABLET, FILM COATED in 1 BOTTLE (63187-283-60) 2019-01-010000-00-00NoNoCurrent
63187-283-906318702839090 TABLET, FILM COATED in 1 BOTTLE (63187-283-90) 2019-01-010000-00-00NoNoCurrent