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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

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