FDA.reportPublic FDA data

Topamax

Product NDC
50458-641
11-digit product format
504580641
Labeler code
50458
Product ID
50458-641_1c7483cf-95db-4b1c-ae4c-b11bc95a6ad8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
topiramate
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Janssen Pharmaceuticals, Inc.
Application
NDA020505
Marketing category
NDA
Marketing start
1997-01-01
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
Topamax
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOPIRAMATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0H73WJJ391
Rxcui151226, 151227, 151228, 151229, 152855, 199888, 199889, 199890, 205315, 205316, 845478, 845479

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
50458-641-65Topamax60 in 1 BOTTLETABLET, COATED6030

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50458-641-65EA - Each50458-641bdd8a19b-133c-4a8a-80fd-34c82dfbba8512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
topiramateACTIVE INGREDIENT0H73WJJ391TOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.]14
topiramateACTIVE MOIETY0H73WJJ391TOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.]14
carnauba waxINACTIVE INGREDIENTR12CBM0EIZTOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.]14
cellulose acetateINACTIVE INGREDIENT3J2P07GVB6TOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.]14
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UTOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.]14
gelatinINACTIVE INGREDIENT2G86QN327LTOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.]14
hypromellosesINACTIVE INGREDIENT3NXW29V3WOTOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.]14
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XTOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.]14
magnesium stearateINACTIVE INGREDIENT70097M6I30TOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.]14
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1ATOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.]14
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HTOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.]14
povidonesINACTIVE INGREDIENTFZ989GH94ETOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.]14
raw sugarINACTIVE INGREDIENT8M707QY5GHTOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.]14
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JTOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.]14
sodium starch glycolate type A potatoINACTIVE INGREDIENT5856J3G2A2TOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.]14
sorbitan monolaurateINACTIVE INGREDIENT6W9PS8B71JTOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.]14
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPTOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.]14
waterINACTIVE INGREDIENT059QF0KO0RTOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.]14
topiramateACTIVE INGREDIENT0H73WJJ391TOPAMAX (TOPIRAMATE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]2
topiramateACTIVE MOIETY0H73WJJ391TOPAMAX (TOPIRAMATE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]2
carnauba waxINACTIVE INGREDIENTR12CBM0EIZTOPAMAX (TOPIRAMATE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]2
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UTOPAMAX (TOPIRAMATE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]2
hypromellosesINACTIVE INGREDIENT3NXW29V3WOTOPAMAX (TOPIRAMATE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]2
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XTOPAMAX (TOPIRAMATE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]2
magnesium stearateINACTIVE INGREDIENT70097M6I30TOPAMAX (TOPIRAMATE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]2
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1ATOPAMAX (TOPIRAMATE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]2
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HTOPAMAX (TOPIRAMATE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]2
sodium starch glycolate type A potatoINACTIVE INGREDIENT5856J3G2A2TOPAMAX (TOPIRAMATE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPTOPAMAX (TOPIRAMATE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]2
waterINACTIVE INGREDIENT059QF0KO0RTOPAMAX (TOPIRAMATE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]2
topiramateACTIVE INGREDIENT0H73WJJ391TOPAMAX (TOPIRAMATE) TABLET, COATED [REBEL DISTRIBUTORS CORP]1
topiramateACTIVE MOIETY0H73WJJ391TOPAMAX (TOPIRAMATE) TABLET, COATED [REBEL DISTRIBUTORS CORP]1
carnauba waxINACTIVE INGREDIENTR12CBM0EIZTOPAMAX (TOPIRAMATE) TABLET, COATED [REBEL DISTRIBUTORS CORP]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UTOPAMAX (TOPIRAMATE) TABLET, COATED [REBEL DISTRIBUTORS CORP]1
hypromellosesINACTIVE INGREDIENT3NXW29V3WOTOPAMAX (TOPIRAMATE) TABLET, COATED [REBEL DISTRIBUTORS CORP]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XTOPAMAX (TOPIRAMATE) TABLET, COATED [REBEL DISTRIBUTORS CORP]1
magnesium stearateINACTIVE INGREDIENT70097M6I30TOPAMAX (TOPIRAMATE) TABLET, COATED [REBEL DISTRIBUTORS CORP]1
polyethylene glycolINACTIVE INGREDIENT3WJQ0SDW1ATOPAMAX (TOPIRAMATE) TABLET, COATED [REBEL DISTRIBUTORS CORP]1
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HTOPAMAX (TOPIRAMATE) TABLET, COATED [REBEL DISTRIBUTORS CORP]1
sodium starch glycolate type A potatoINACTIVE INGREDIENT5856J3G2A2TOPAMAX (TOPIRAMATE) TABLET, COATED [REBEL DISTRIBUTORS CORP]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPTOPAMAX (TOPIRAMATE) TABLET, COATED [REBEL DISTRIBUTORS CORP]1
waterINACTIVE INGREDIENT059QF0KO0RTOPAMAX (TOPIRAMATE) TABLET, COATED [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50458-641TOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.]28Current NDC, Legacy NDC, 1 package rows20250326_21628112-0c47-11df-95b3-498d55d89593.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
151228Topamax 100 MG Oral TabletPSN21628112-0c47-11df-95b3-498d55d8959330
845478Topamax 15 MG Oral Sprinkle CapsulePSN21628112-0c47-11df-95b3-498d55d8959330
151229Topamax 200 MG Oral TabletPSN21628112-0c47-11df-95b3-498d55d8959330
845479Topamax 25 MG Oral Sprinkle CapsulePSN21628112-0c47-11df-95b3-498d55d8959330
152855Topamax 25 MG Oral TabletPSN21628112-0c47-11df-95b3-498d55d8959330
151227Topamax 50 MG Oral TabletPSN21628112-0c47-11df-95b3-498d55d8959330
199889topiramate 100 MG Oral TabletPSN21628112-0c47-11df-95b3-498d55d8959330
205316topiramate 15 MG Oral CapsulePSN21628112-0c47-11df-95b3-498d55d8959330
199890topiramate 200 MG Oral TabletPSN21628112-0c47-11df-95b3-498d55d8959330
205315topiramate 25 MG Oral CapsulePSN21628112-0c47-11df-95b3-498d55d8959330
199888topiramate 25 MG Oral TabletPSN21628112-0c47-11df-95b3-498d55d8959330
151226topiramate 50 MG Oral TabletPSN21628112-0c47-11df-95b3-498d55d8959330
151228topiramate 100 MG Oral Tablet [Topamax]SBD21628112-0c47-11df-95b3-498d55d8959330
845478topiramate 15 MG Oral Capsule [Topamax]SBD21628112-0c47-11df-95b3-498d55d8959330
151229topiramate 200 MG Oral Tablet [Topamax]SBD21628112-0c47-11df-95b3-498d55d8959330
845479topiramate 25 MG Oral Capsule [Topamax]SBD21628112-0c47-11df-95b3-498d55d8959330
152855topiramate 25 MG Oral Tablet [Topamax]SBD21628112-0c47-11df-95b3-498d55d8959330
151227topiramate 50 MG Oral Tablet [Topamax]SBD21628112-0c47-11df-95b3-498d55d8959330
199889topiramate 100 MG Oral TabletSCD21628112-0c47-11df-95b3-498d55d8959330
205316topiramate 15 MG Oral CapsuleSCD21628112-0c47-11df-95b3-498d55d8959330
199890topiramate 200 MG Oral TabletSCD21628112-0c47-11df-95b3-498d55d8959330
205315topiramate 25 MG Oral CapsuleSCD21628112-0c47-11df-95b3-498d55d8959330
199888topiramate 25 MG Oral TabletSCD21628112-0c47-11df-95b3-498d55d8959330
151226topiramate 50 MG Oral TabletSCD21628112-0c47-11df-95b3-498d55d8959330
151228Topamax 100 MG Oral TabletSY21628112-0c47-11df-95b3-498d55d8959330
845478Topamax 15 MG Oral CapsuleSY21628112-0c47-11df-95b3-498d55d8959330
151229Topamax 200 MG Oral TabletSY21628112-0c47-11df-95b3-498d55d8959330
845479Topamax 25 MG Oral CapsuleSY21628112-0c47-11df-95b3-498d55d8959330
152855Topamax 25 MG Oral TabletSY21628112-0c47-11df-95b3-498d55d8959330
151227Topamax 50 MG Oral TabletSY21628112-0c47-11df-95b3-498d55d8959330
151228Topamax 100 MG Oral TabletPSN88c9d1ca-f3a8-4078-8de7-21fd9040dd202
151229Topamax 200 MG Oral TabletPSN88c9d1ca-f3a8-4078-8de7-21fd9040dd202
152855Topamax 25 MG Oral TabletPSN88c9d1ca-f3a8-4078-8de7-21fd9040dd202
151227Topamax 50 MG Oral TabletPSN88c9d1ca-f3a8-4078-8de7-21fd9040dd202
199889topiramate 100 MG Oral TabletPSN88c9d1ca-f3a8-4078-8de7-21fd9040dd202
199890topiramate 200 MG Oral TabletPSN88c9d1ca-f3a8-4078-8de7-21fd9040dd202
199888topiramate 25 MG Oral TabletPSN88c9d1ca-f3a8-4078-8de7-21fd9040dd202
151226topiramate 50 MG Oral TabletPSN88c9d1ca-f3a8-4078-8de7-21fd9040dd202
151228topiramate 100 MG Oral Tablet [Topamax]SBD88c9d1ca-f3a8-4078-8de7-21fd9040dd202
151229topiramate 200 MG Oral Tablet [Topamax]SBD88c9d1ca-f3a8-4078-8de7-21fd9040dd202
152855topiramate 25 MG Oral Tablet [Topamax]SBD88c9d1ca-f3a8-4078-8de7-21fd9040dd202
151227topiramate 50 MG Oral Tablet [Topamax]SBD88c9d1ca-f3a8-4078-8de7-21fd9040dd202
199889topiramate 100 MG Oral TabletSCD88c9d1ca-f3a8-4078-8de7-21fd9040dd202
199890topiramate 200 MG Oral TabletSCD88c9d1ca-f3a8-4078-8de7-21fd9040dd202
199888topiramate 25 MG Oral TabletSCD88c9d1ca-f3a8-4078-8de7-21fd9040dd202
151226topiramate 50 MG Oral TabletSCD88c9d1ca-f3a8-4078-8de7-21fd9040dd202
151228Topamax 100 MG Oral TabletSY88c9d1ca-f3a8-4078-8de7-21fd9040dd202
151229Topamax 200 MG Oral TabletSY88c9d1ca-f3a8-4078-8de7-21fd9040dd202
152855Topamax 25 MG Oral TabletSY88c9d1ca-f3a8-4078-8de7-21fd9040dd202
151227Topamax 50 MG Oral TabletSY88c9d1ca-f3a8-4078-8de7-21fd9040dd202
151228Topamax 100 MG Oral TabletPSN202b1a2a-11dc-4c3d-aa53-27512a98a0421
152855Topamax 25 MG Oral TabletPSN202b1a2a-11dc-4c3d-aa53-27512a98a0421
151227Topamax 50 MG Oral TabletPSN202b1a2a-11dc-4c3d-aa53-27512a98a0421
199889topiramate 100 MG Oral TabletPSN202b1a2a-11dc-4c3d-aa53-27512a98a0421
199888topiramate 25 MG Oral TabletPSN202b1a2a-11dc-4c3d-aa53-27512a98a0421
151226topiramate 50 MG Oral TabletPSN202b1a2a-11dc-4c3d-aa53-27512a98a0421
151228topiramate 100 MG Oral Tablet [Topamax]SBD202b1a2a-11dc-4c3d-aa53-27512a98a0421
152855topiramate 25 MG Oral Tablet [Topamax]SBD202b1a2a-11dc-4c3d-aa53-27512a98a0421
151227topiramate 50 MG Oral Tablet [Topamax]SBD202b1a2a-11dc-4c3d-aa53-27512a98a0421
199889topiramate 100 MG Oral TabletSCD202b1a2a-11dc-4c3d-aa53-27512a98a0421
199888topiramate 25 MG Oral TabletSCD202b1a2a-11dc-4c3d-aa53-27512a98a0421
151226topiramate 50 MG Oral TabletSCD202b1a2a-11dc-4c3d-aa53-27512a98a0421
151228Topamax 100 MG Oral TabletSY202b1a2a-11dc-4c3d-aa53-27512a98a0421
152855Topamax 25 MG Oral TabletSY202b1a2a-11dc-4c3d-aa53-27512a98a0421
151227Topamax 50 MG Oral TabletSY202b1a2a-11dc-4c3d-aa53-27512a98a0421

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50458-641-655045806416560 TABLET, COATED in 1 BOTTLE (50458-641-65) 1997-01-010000-00-00NoNoCurrent