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
35f26d3c-268b-4114-9b5b-1c2e0b9ddfd5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 22, 2022
Manufacturers
FDA
Unichem Pharmaceuticals (USA), Inc.
DUNS: 181620514
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 Code29300-317
Application NumberANDA207836
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rizatriptan Benzoate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 22, 2022
FDA Product Classification
INGREDIENTS (5)
RIZATRIPTAN BENZOATEActive
Quantity: 10 mg in 1 1
Code: WR978S7QHH
Classification: ACTIM
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
Rizatriptan Benzoate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code29300-316
Application NumberANDA207836
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rizatriptan Benzoate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 22, 2022
FDA Product Classification
INGREDIENTS (5)
RIZATRIPTAN BENZOATEActive
Quantity: 5 mg in 1 1
Code: WR978S7QHH
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT