LEXISCAN(R) (REGADENOSON)
LEXISCAN(R) (REGADENOSON) INJECTION 0.4mg/5mL (0.08 mg/mL) 5mL SYR
Approved
Approval ID
99640071-4db2-9317-e053-2995a90a610d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 28, 2024
Manufacturers
FDA
HF Acquisition Co LLC, DBA HealthFirst
DUNS: 045657305
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
LEXISCAN(R) (REGADENOSON)
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51662-1448
Application NumberNDA022161
Product Classification
M
Marketing Category
C73594
G
Generic Name
LEXISCAN(R) (REGADENOSON)
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 28, 2024
FDA Product Classification
INGREDIENTS (1)
REGADENOSONActive
Quantity: 0.08 mg in 1 mL
Code: 2XLN4Y044H
Classification: ACTIM