Regadenoson
These highlights do not include all the information needed to use REGADENOSON INJECTION safely and effectively. See full prescribing information for REGADENOSON INJECTION. REGADENOSON injection, for intravenous use Initial U.S. Approval: 2008
Approved
Approval ID
5e4109f0-4875-4f8e-b70d-4055b3a785a3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 15, 2022
Manufacturers
FDA
Gland Pharma Limited
DUNS: 918601238
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Regadenoson
PRODUCT DETAILS
NDC Product Code68083-175
Application NumberANDA207320
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateJuly 15, 2022
Generic NameRegadenoson
INGREDIENTS (6)
REGADENOSONActive
Quantity: 0.08 mg in 1 mL
Code: 2XLN4Y044H
Classification: ACTIM
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Quantity: 10.9 mg in 1 mL
Code: 94255I6E2T
Classification: IACT
PROPYLENE GLYCOLInactive
Quantity: 150 mg in 1 mL
Code: 6DC9Q167V3
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Quantity: 5.4 mg in 1 mL
Code: 593YOG76RN
Classification: IACT
EDETATE DISODIUMInactive
Quantity: 1 mg in 1 mL
Code: 7FLD91C86K
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT