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
03ef6420-8190-a404-f7f6-def1864a77de
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 1, 2022
Manufacturers
FDA
Dr. Reddy's Laboratories Inc.
DUNS: 802315887
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 Code43598-616
Application NumberANDA213210
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateMarch 25, 2019
Generic NameRegadenoson
INGREDIENTS (6)
Sodium Phosphate, Monobasic, MonohydrateInactive
Quantity: 5.4 mg in 1 mL
Code: 593YOG76RN
Classification: IACT
PROPYLENE GLYCOLInactive
Quantity: 150 mg in 1 mL
Code: 6DC9Q167V3
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
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
Edetate DisodiumInactive
Quantity: 1 mg in 1 mL
Code: 7FLD91C86K
Classification: IACT