Rizatriptan Benzoate
These highlights do not include all the information needed to use RIZATRIPTAN BENZOATE TABLETS safely and effectively. See full prescribing information for RIZATRIPTAN BENZOATE TABLETS. RIZATRIPTAN benzoate tablets, for oral useInitial U.S. Approval: 1998
Approved
Approval ID
9e82135a-3371-4012-92af-0cc7d7d4d0e3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 1, 2020
Manufacturers
FDA
Exelan Pharmaceuticals Inc.
DUNS: 967795266
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Rizatriptan Benzoate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76282-462
Application NumberANDA204339
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rizatriptan Benzoate
Product Specifications
Route of AdministrationORAL
Effective DateMay 1, 2020
FDA Product Classification
INGREDIENTS (7)
RIZATRIPTAN BENZOATEActive
Quantity: 5 mg in 1 1
Code: WR978S7QHH
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Rizatriptan Benzoate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76282-463
Application NumberANDA204339
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rizatriptan Benzoate
Product Specifications
Route of AdministrationORAL
Effective DateMay 1, 2020
FDA Product Classification
INGREDIENTS (7)
RIZATRIPTAN BENZOATEActive
Quantity: 10 mg in 1 1
Code: WR978S7QHH
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT