Regadenoson

Product NDC
72611-874
11-digit product format
726110874
Labeler code
72611
Product ID
72611-874_442e8404-64f2-db43-c8d9-0f4986ac49fa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Regadenoson
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Almaject, Inc.
Application
ANDA207320
Marketing category
ANDA
Marketing start
2023-07-03
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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
60758f30-9b07-ad4c-2eb4-c357ebb784a4Product name520250317
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72611-874-01Regadenoson5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION53
72611-874-10Regadenoson10 in 1 CARTONINJECTION, SOLUTION103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72611-874-01ML - Milliliter72611-874e08fb07b-71a3-40a1-9ae4-66c03a99aaea12023-08-08
72611-874-10ML - Milliliter72611-87433bcf72b-ced1-4f59-94f1-8c3d01404f3b12023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72611-874REGADENOSON INJECTION, SOLUTION [ALMAJECT, INC.]2Current NDC, 2 package rows20241009_991f6634-2d5c-6ceb-4bee-22fd144a6ff7.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72611-874-01726110874015 mL in 1 VIAL, SINGLE-DOSE5 mlHistorical
72611-874-107261108741010 VIAL, SINGLE-DOSE in 1 CARTON (72611-874-10) / 5 mL in 1 VIAL, SINGLE-DOSE (72611-874-01) 2023-07-03NoNoHistorical