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 use Initial U.S. Approval: 1992
Approved
Approval ID
d3b61201-fb84-446b-83a6-b72e8e1d6d04
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 7, 2023
Manufacturers
FDA
RPK Pharmaceuticals, Inc.
DUNS: 147096275
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 Code53002-1592
Application NumberANDA076847
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sumatriptan Succinate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 10, 2020
FDA Product Classification
INGREDIENTS (10)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SUMATRIPTAN SUCCINATEActive
Quantity: 50 mg in 1 1
Code: J8BDZ68989
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
Sumatriptan Succinate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53002-2562
Application NumberANDA076847
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sumatriptan Succinate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 10, 2020
FDA Product Classification
INGREDIENTS (10)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SUMATRIPTAN SUCCINATEActive
Quantity: 100 mg in 1 1
Code: J8BDZ68989
Classification: ACTIM
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Sumatriptan Succinate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53002-1593
Application NumberANDA076847
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sumatriptan Succinate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 10, 2020
FDA Product Classification
INGREDIENTS (10)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SUMATRIPTAN SUCCINATEActive
Quantity: 25 mg in 1 1
Code: J8BDZ68989
Classification: ACTIM
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT