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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

4a5b43f6-a5ea-4d6f-941f-3c19f242c896

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 1, 2022

Manufacturers
FDA

Proficient Rx LP

DUNS: 079196022

Products 1

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 Code71205-644
Application NumberANDA202490
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rizatriptan Benzoate
Product Specifications
Route of AdministrationORAL
Effective DateMay 1, 2022
FDA Product Classification

INGREDIENTS (6)

RIZATRIPTAN BENZOATEActive
Quantity: 10 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
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT

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Rizatriptan Benzoate - FDA Drug Approval Details