Sumatriptan
These highlights do not include all the information needed to use SUMATRIPTAN TABLETS, USP safely and effectively. See full prescribing information for SUMATRIPTAN TABLETS, USP. SUMATRIPTAN tablets, USP, for oral use Initial U.S. Approval: 1992
Approved
Approval ID
c87cf537-9f7f-400e-ac4b-86e6f7e78775
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 19, 2022
Manufacturers
FDA
SUN PHARMACEUTICAL INDUSTRIES, INC.
DUNS: 146974886
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Sumatriptan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63304-098
Application NumberANDA076554
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sumatriptan
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 19, 2022
FDA Product Classification
INGREDIENTS (8)
SUMATRIPTAN SUCCINATEActive
Quantity: 50 mg in 1 1
Code: J8BDZ68989
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Sumatriptan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63304-097
Application NumberANDA076554
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sumatriptan
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 19, 2022
FDA Product Classification
INGREDIENTS (8)
SUMATRIPTAN SUCCINATEActive
Quantity: 25 mg in 1 1
Code: J8BDZ68989
Classification: ACTIM
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
Sumatriptan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63304-099
Application NumberANDA076572
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sumatriptan
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 19, 2022
FDA Product Classification
INGREDIENTS (8)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SUMATRIPTAN SUCCINATEActive
Quantity: 100 mg in 1 1
Code: J8BDZ68989
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT