Adenosine
These highlights do not include all the information needed to use ADENOSINE INJECTION safely and effectively. See full prescribing information for ADENOSINE INJECTION. ADENOSINE injection, for intravenous useInitial U.S. Approval: 1995
Approved
Approval ID
b6851256-6cef-4f23-8129-19bb64380cd5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 14, 2025
Manufacturers
FDA
Meitheal Pharmaceuticals Inc.
DUNS: 080548348
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Adenosine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71288-208
Application NumberANDA077425
Product Classification
M
Marketing Category
C73584
G
Generic Name
Adenosine
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 14, 2025
FDA Product Classification
INGREDIENTS (3)
ADENOSINEActive
Quantity: 3 mg in 1 mL
Code: K72T3FS567
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Adenosine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71288-207
Application NumberANDA077425
Product Classification
M
Marketing Category
C73584
G
Generic Name
Adenosine
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 14, 2025
FDA Product Classification
INGREDIENTS (3)
ADENOSINEActive
Quantity: 3 mg in 1 mL
Code: K72T3FS567
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT