Regadenoson

Product NDC
60505-6288
11-digit product format
605056288
Labeler code
60505
Product ID
60505-6288_a21106e5-4b14-7a34-523c-eb93b424d43d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
regadenoson
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Apotex Corp.
Application
ANDA207604
Marketing category
ANDA
Marketing start
2025-04-03
Substance
REGADENOSON
Active strength
.08 mg/mL
Pharmacologic classes
Adenosine Receptor Agonists [MoA], Pharmacologic Cardiac Stress Test Agent [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
2XLN4Y044HREGADENOSON875148-45-1REGADENOSON

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
60505-6288-0605056288001 SYRINGE, PLASTIC in 1 CARTON (60505-6288-0) / 5 mL in 1 SYRINGE, PLASTIC2025-04-03NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
RegadenosonApotex Corp. | Apotex Inc.2025-04-03HUMAN PRESCRIPTION DRUG LABEL2