MAXALT-MLT
Approved
Approval ID
08d06e6f-a1d8-4bd9-b851-d63858d55f91
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 22, 2011
Manufacturers
FDA
STAT RX USA LLC
DUNS: 786036330
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 Code16590-144
Application NumberNDA020865
Product Classification
M
Marketing Category
C73594
G
Generic Name
RIZATRIPTAN BENZOATE
Product Specifications
Route of AdministrationORAL
Effective DateApril 4, 2011
FDA Product Classification
INGREDIENTS (5)
GELATINInactive
Code: 2G86QN327L
Classification: IACT
RIZATRIPTAN BENZOATEActive
Quantity: 5 mg in 1 1
Code: WR978S7QHH
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
GLYCINEInactive
Code: TE7660XO1C
Classification: IACT
RIZATRIPTAN BENZOATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-461
Application NumberNDA020864
Product Classification
M
Marketing Category
C73594
G
Generic Name
RIZATRIPTAN BENZOATE
Product Specifications
Route of AdministrationORAL
Effective DateApril 4, 2011
FDA Product Classification
INGREDIENTS (6)
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
RIZATRIPTAN BENZOATEActive
Quantity: 10 mg in 1 1
Code: WR978S7QHH
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT