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 useInitial U.S. Approval: 2008
Approved
Approval ID
288c76cc-ff3e-47ea-ae02-be566bd3e093
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 20, 2023
Manufacturers
FDA
International Medication Systems, Limited
DUNS: 055750020
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 Code76329-3321
Application NumberANDA214252
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateApril 20, 2023
Generic NameRegadenoson
INGREDIENTS (7)
REGADENOSON ANHYDROUSActive
Quantity: 0.08 mg in 1 mL
Code: 7AXV542LZ4
Classification: ACTIB
SODIUM PHOSPHATE DIBASIC DIHYDRATEInactive
Quantity: 10.9 mg in 1 mL
Code: 94255I6E2T
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Quantity: 8.7 mg in 1 mL
Code: 22ADO53M6F
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
PROPYLENE GLYCOLInactive
Quantity: 150 mg in 1 mL
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT