LEXISCAN

Product NDC
0469-6501
11-digit product format
004696501
Labeler code
0469
Product ID
0469-6501_8fb5b92b-3654-43ff-98d3-3ac23c9a0b10
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
regadenoson
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Astellas Pharma US, Inc.
Application
NDA022161
Marketing category
NDA
Marketing start
2008-04-10
Substance
REGADENOSON
Active strength
.08 mg/mL
Pharmacologic classes
Adenosine Receptor Agonist [EPC], Adenosine Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
LEXISCAN
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0469-6501-89LEXISCAN5 mL in 1 SYRINGE, PLASTICINJECTION, SOLUTION513

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0469-6501LEXISCAN (REGADENOSON) INJECTION, SOLUTION [ASTELLAS PHARMA US, INC.]13Current NDC, Legacy NDC, 1 package rows20190129_057289f4-2e18-4c1e-bed4-6c1858e2ef16.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0469-6501-89004696501895 mL in 1 SYRINGE, PLASTIC (0469-6501-89) 5 ml2008-04-100000-00-00NoNoCurrent