Topiramate
These highlights do not include all the information needed to use TOPIRAMATE CAPSULES safely and effectively. See full prescribing information for TOPIRAMATE CAPSULES TOPIRAMATE capsules, for oral use Initial U.S. Approval: 1996
Approved
Approval ID
e0d88f34-865c-441b-80e2-e814c9a7d670
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 5, 2023
Manufacturers
FDA
TWi Pharmaceuticals, Inc.
DUNS: 658402052
FDA
Upsher-Smith Laboratories, LLC
DUNS: 047251004
Products 2
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 Code24979-210
Application NumberANDA217694
Product Classification
M
Marketing Category
C73584
G
Generic Name
Topiramate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 6, 2023
FDA Product Classification
INGREDIENTS (7)
TOPIRAMATEActive
Quantity: 15 mg in 1 1
Code: 0H73WJJ391
Classification: ACTIB
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
CELLULOSE ACETATEInactive
Code: 3J2P07GVB6
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
Topiramate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24979-211
Application NumberANDA217694
Product Classification
M
Marketing Category
C73584
G
Generic Name
Topiramate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 6, 2023
FDA Product Classification
INGREDIENTS (7)
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
TOPIRAMATEActive
Quantity: 25 mg in 1 1
Code: 0H73WJJ391
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE ACETATEInactive
Code: 3J2P07GVB6
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT