Regadenoson
These highlights do not include all the information needed to use REGADENOSON safely and effectively. See full prescribing information for REGADENOSON . REGADENOSON injection, for intravenous use Initial U.S. Approval: 2008
Approved
Approval ID
af131207-097f-3901-e711-fba004944076
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 14, 2023
Manufacturers
FDA
Apotex Corp.
DUNS: 845263701
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 Code60505-6116
Application NumberANDA207604
Product Classification
M
Marketing Category
C73584
G
Generic Name
regadenoson
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 14, 2023
FDA Product Classification
INGREDIENTS (6)
REGADENOSONActive
Quantity: 0.08 mg in 1 mL
Code: 2XLN4Y044H
Classification: ACTIM
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Code: 94255I6E2T
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Code: 593YOG76RN
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT