Regadenoson

Product NDC
67457-994
11-digit product format
674570994
Labeler code
67457
Product ID
67457-994_e6bccf18-bc12-4f68-a021-af21b5026e16
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Regadenoson
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Mylan Institutional LLC
Application
ANDA213856
Marketing category
ANDA
Marketing start
2023-09-21
Marketing end
2026-06-30
Substance
REGADENOSON
Active strength
.4 mg/5mL
Pharmacologic classes
Adenosine Receptor Agonists [MoA], Pharmacologic Cardiac Stress Test Agent [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
2XLN4Y044HREGADENOSON875148-45-1REGADENOSON

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67457-994-05674570994051 SYRINGE in 1 CARTON (67457-994-05) / 5 mL in 1 SYRINGE1 syringe2023-09-212026-06-30NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
RegadenosonMylan Institutional LLC2022-11-15HUMAN PRESCRIPTION DRUG LABEL3