Regadenoson
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for .REGADENOSON injection, for intravenous useInitial U.S. Approval: 2008
Approved
Approval ID
e1ab38bf-cfd0-444f-a8a6-bb8588b63228
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 9, 2021
Manufacturers
FDA
Mylan Institutional LLC
DUNS: 790384502
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 Code67457-994
Application NumberANDA213856
Product Classification
M
Marketing Category
C73584
G
Generic Name
Regadenoson
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 9, 2021
FDA Product Classification
INGREDIENTS (5)
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Code: 593YOG76RN
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
REGADENOSONActive
Quantity: 0.4 mg in 5 mL
Code: 2XLN4Y044H
Classification: ACTIM
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Code: 94255I6E2T
Classification: IACT