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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76329-3321
Application NumberANDA214252
Product Classification
M
Marketing Category
C73584
G
Generic Name
Regadenoson
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 20, 2023
FDA Product Classification
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