FDA.reportPublic FDA data

NDC 51662-1448-01 - LEXISCAN(R) (REGADENOSON)

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
51662-1448
Requested NDC
51662-1448-01
Package NDCs from labels
51662-1448-1, 51662-1448-01
Manufacturer
HF Acquisition Co LLC, DBA HealthFirst
Effective date
2024-01-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
LEXISCAN(R) (REGADENOSON) - HF Acquisition Co LLC, DBA HealthFirstHF Acquisition Co LLC, DBA HealthFirst2024-01-28HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1448-1LEXISCAN(R) (REGADENOSON)5 mL in 1 SYRINGE, PLASTICINJECTION, SOLUTION54
51662-1448-1LEXISCAN(R) (REGADENOSON)1 in 1 CARTONINJECTION, SOLUTION14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1448LEXISCAN(R) (REGADENOSON) INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]4Current NDC, Legacy NDC, 2 package rows20240129_99640071-4db2-9317-e053-2995a90a610d.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 ยท 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RegadenosonREGADENOSONIndies Pharma Jamaica Limited5095ab40-8503-46db-9b08-6a36f05fb5d92025-12-26Warnings, Adverse reactionsExact identifier
unii: 2XLN4Y044H
RegadenosonREGADENOSONKanchan Healthcare Incb183399d-b8dc-4924-90cd-a1c2247742f32025-08-15Warnings, Adverse reactionsExact identifier
unii: 2XLN4Y044H
RegadenosonREGADENOSONMarlex Pharmaceuticals, Inc.843bfba9-47de-4d76-843a-997bb4564f6e2025-02-02Warnings, Adverse reactionsExact identifier
unii: 2XLN4Y044H
regadenosonREGADENOSONBaxter Healthcare Corporationa81d66a7-b714-439e-ad7b-c7caf9d6f3b82024-09-25Warnings, Adverse reactionsExact identifier
unii: 2XLN4Y044H
LEXISCAN(R) (REGADENOSON)LEXISCAN(R) (REGADENOSON)HF Acquisition Co LLC, DBA HealthFirst99640071-4db2-9317-e053-2995a90a610d2024-01-28Warnings, Adverse reactionsExact identifier
application number: NDA022161
ndc (package): 51662-1448-1
ndc (product): 51662-1448
ndc11 (package): 51662144801
spl id: 0ffbfae4-66b6-b616-e063-6294a90a2d06
spl set id: 99640071-4db2-9317-e053-2995a90a610d
unii: 2XLN4Y044H
regadenosonREGADENOSONEugia US LLCb553eb2d-0c3f-444e-ad4c-2823286831102023-12-18Warnings, Adverse reactionsExact identifier
unii: 2XLN4Y044H
RegadenosonREGADENOSONGland Pharma Limited5e4109f0-4875-4f8e-b70d-4055b3a785a32022-07-15Warnings, Adverse reactionsExact identifier
unii: 2XLN4Y044H
RegadenosonREGADENOSONMeitheal Pharmaceuticals Inc.a550b451-fb30-4c1c-a60e-6e40fba20c882022-04-15Warnings, Adverse reactionsExact identifier
unii: 2XLN4Y044H
LEXISCANREGADENOSONAstellas Pharma US, Inc.057289f4-2e18-4c1e-bed4-6c1858e2ef162018-12-21Warnings, Adverse reactionsExact identifier
application number: NDA022161
ndc (product): 0469-6501
spl id: 8fb5b92b-3654-43ff-98d3-3ac23c9a0b10
spl set id: 057289f4-2e18-4c1e-bed4-6c1858e2ef16
unii: 2XLN4Y044H

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.