FDA.reportPublic FDA data

Regadenoson

Product NDC
68083-175
11-digit product format
680830175
Labeler code
68083
Product ID
68083-175_549593f6-8cfc-4182-8f3c-a60870187d8f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Regadenoson
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Gland Pharma Limited
Application
ANDA207320
Marketing category
ANDA
Marketing start
2022-07-12
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

Additional Listing Data#

Finished product
Yes
Brand name base
Regadenoson
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
REGADENOSON.08 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2XLN4Y044H

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
68083-175-01Regadenoson5 mL in 1 VIALINJECTION, SOLUTION55
68083-175-10Regadenoson10 in 1 CARTONINJECTION, SOLUTION105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-175REGADENOSON INJECTION, SOLUTION [GLAND PHARMA LIMITED]5Current NDC, Legacy NDC, 2 package rows20220717_5e4109f0-4875-4f8e-b70d-4055b3a785a3.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68083-175-01680830175015 mL in 1 VIAL5 mlHistorical
68083-175-106808301751010 VIAL in 1 CARTON (68083-175-10) / 5 mL in 1 VIAL (68083-175-01) 10 vial2022-07-120000-00-00NoNoCurrent