Adenosine
Rx only
Approved
Approval ID
ab2edabd-e57d-4754-9822-93bd17af9e88
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 4, 2017
Manufacturers
FDA
Gland Pharma Limited
DUNS: 918601238
Products 1
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 Code68083-101
Application NumberANDA077283
Product Classification
M
Marketing Category
C73584
G
Generic Name
Adenosine
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 4, 2017
FDA Product Classification
INGREDIENTS (3)
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
AdenosineActive
Quantity: 3 mg in 1 mL
Code: K72T3FS567
Classification: ACTIB