Topamax
These highlights do not include all the information needed to use TOPAMAX safely and effectively. See full prescribing information for TOPAMAX TOPAMAX (topiramate) TABLETS for oral use TOPAMAX (topiramate capsules) SPRINKLE CAPSULES for oral use Initial U.S. Approval – 1996
Approved
Approval ID
88c9d1ca-f3a8-4078-8de7-21fd9040dd20
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 14, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
topiramate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4674
Application NumberNDA020505
Product Classification
M
Marketing Category
C73594
G
Generic Name
topiramate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 14, 2012
FDA Product Classification
INGREDIENTS (11)
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
topiramateActive
Quantity: 100 mg in 1 1
Code: 0H73WJJ391
Classification: ACTIB
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
sodium starch glycolate type A potatoInactive
Code: 5856J3G2A2
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
carnauba waxInactive
Code: R12CBM0EIZ
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
hypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
polyethylene glycolsInactive
Code: 3WJQ0SDW1A
Classification: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
topiramate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4672
Application NumberNDA020505
Product Classification
M
Marketing Category
C73594
G
Generic Name
topiramate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 14, 2012
FDA Product Classification
INGREDIENTS (11)
topiramateActive
Quantity: 25 mg in 1 1
Code: 0H73WJJ391
Classification: ACTIB
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
sodium starch glycolate type A potatoInactive
Code: 5856J3G2A2
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
hypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
carnauba waxInactive
Code: R12CBM0EIZ
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
polyethylene glycolsInactive
Code: 3WJQ0SDW1A
Classification: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
topiramate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5190
Application NumberNDA020505
Product Classification
M
Marketing Category
C73594
G
Generic Name
topiramate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 14, 2012
FDA Product Classification
INGREDIENTS (11)
topiramateActive
Quantity: 200 mg in 1 1
Code: 0H73WJJ391
Classification: ACTIB
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
sodium starch glycolate type A potatoInactive
Code: 5856J3G2A2
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
hypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
carnauba waxInactive
Code: R12CBM0EIZ
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
polyethylene glycolsInactive
Code: 3WJQ0SDW1A
Classification: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
topiramate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5343
Application NumberNDA020505
Product Classification
M
Marketing Category
C73594
G
Generic Name
topiramate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 14, 2012
FDA Product Classification
INGREDIENTS (11)
topiramateActive
Quantity: 50 mg in 1 1
Code: 0H73WJJ391
Classification: ACTIB
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
sodium starch glycolate type A potatoInactive
Code: 5856J3G2A2
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
polyethylene glycolsInactive
Code: 3WJQ0SDW1A
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
carnauba waxInactive
Code: R12CBM0EIZ
Classification: IACT
hypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT