SUMATRIPTAN
These highlights do not include all the information needed to use sumatriptan safely and effectively. See full prescribing information for sumatriptan. SU MATRIPTAN Injection, USP, for subcutaneous use Initial U.S. Approval: 1992
Approved
Approval ID
2b417f8c-9e5b-45a1-b8af-183818258df9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 1, 2021
Manufacturers
FDA
Hikma Pharmaceuticals USA Inc.
DUNS: 001230762
Products 1
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 Code0143-9638
Application NumberANDA200183
Product Classification
M
Marketing Category
C73584
G
Generic Name
sumatriptan
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJanuary 1, 2021
FDA Product Classification
INGREDIENTS (3)
SUMATRIPTAN SUCCINATEActive
Quantity: 6 mg in 0.5 mL
Code: J8BDZ68989
Classification: ACTIM
SODIUM CHLORIDEInactive
Quantity: 3.5 mg in 0.5 mL
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT