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 use Initial U.S. Approval: 1998
Approved
Approval ID
b517896b-167e-47d5-801d-7458f80e8ee2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 7, 2023
Manufacturers
FDA
Creekwood Pharmaceuticals LLC
DUNS: 118582565
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 Code82619-112
Application NumberANDA202047
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rizatriptan Benzoate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 13, 2023
FDA Product Classification
INGREDIENTS (6)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
RIZATRIPTAN BENZOATEActive
Quantity: 10 mg in 1 1
Code: WR978S7QHH
Classification: ACTIM
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
Rizatriptan Benzoate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code82619-111
Application NumberANDA202047
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rizatriptan Benzoate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 13, 2023
FDA Product Classification
INGREDIENTS (6)
RIZATRIPTAN BENZOATEActive
Quantity: 5 mg in 1 1
Code: WR978S7QHH
Classification: ACTIM
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT