Sumatriptan Succinate
These highlights do not include all the information needed to use SUMATRIPTAN TABLETS safely and effectively. See full prescribing information for SUMATRIPTAN TABLETS. SUMATRIPTAN tablets for oral useInitial U.S. Approval: 1992
Approved
Approval ID
1d2cd01c-05e7-44cf-a71d-0f474e826b7e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 15, 2023
Manufacturers
FDA
Mylan Pharmaceuticals Inc.
DUNS: 059295980
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
sumatriptan succinate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-5630
Application NumberANDA077744
Product Classification
M
Marketing Category
C73584
G
Generic Name
sumatriptan succinate
Product Specifications
Route of AdministrationORAL
Effective DateJuly 16, 2018
FDA Product Classification
INGREDIENTS (13)
SUMATRIPTAN SUCCINATEActive
Quantity: 25 mg in 1 1
Code: J8BDZ68989
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
sumatriptan succinate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-5631
Application NumberANDA077744
Product Classification
M
Marketing Category
C73584
G
Generic Name
sumatriptan succinate
Product Specifications
Route of AdministrationORAL
Effective DateJuly 16, 2018
FDA Product Classification
INGREDIENTS (13)
SUMATRIPTAN SUCCINATEActive
Quantity: 50 mg in 1 1
Code: J8BDZ68989
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
sumatriptan succinate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-5632
Application NumberANDA077744
Product Classification
M
Marketing Category
C73584
G
Generic Name
sumatriptan succinate
Product Specifications
Route of AdministrationORAL
Effective DateJuly 16, 2018
FDA Product Classification
INGREDIENTS (13)
SUMATRIPTAN SUCCINATEActive
Quantity: 100 mg in 1 1
Code: J8BDZ68989
Classification: ACTIM
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT