MAXALT
These highlights do not include all the information needed to use MAXALT and MAXALT-MLT safely and effectively. See full prescribing information for MAXALT and MAXALT-MLT. MAXALT (rizatriptan benzoate) tablets, for oral useMAXALT-MLT (rizatriptan benzoate) orally disintegrating tabletsInitial U.S. Approval: 1998
Approved
Approval ID
3756d8e3-7e89-46c7-8723-6fea65363913
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 14, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-4251
Application NumberNDA020864
Product Classification
M
Marketing Category
C73594
G
Generic Name
rizatriptan benzoate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 14, 2012
FDA Product Classification
INGREDIENTS (6)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
rizatriptan benzoateActive
Quantity: 10 mg in 1 1
Code: WR978S7QHH
Classification: ACTIM
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
rizatriptan benzoate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4499
Application NumberNDA020865
Product Classification
M
Marketing Category
C73594
G
Generic Name
rizatriptan benzoate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 14, 2012
FDA Product Classification
INGREDIENTS (5)
rizatriptan benzoateActive
Quantity: 10 mg in 1 1
Code: WR978S7QHH
Classification: ACTIM
gelatinInactive
Code: 2G86QN327L
Classification: IACT
mannitolInactive
Code: 3OWL53L36A
Classification: IACT
glycineInactive
Code: TE7660XO1C
Classification: IACT
aspartameInactive
Code: Z0H242BBR1
Classification: IACT