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adenosine

Adenosine Injection, USP

Approved
Approval ID

d2d06ee6-c89f-49f7-9e2c-46d33ce877a9

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 20, 2022

Manufacturers
FDA

Mylan Institutional LLC

DUNS: 790384502

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 Code67457-855
Application NumberANDA078686
Product Classification
M
Marketing Category
C73584
G
Generic Name
adenosine
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 20, 2022
FDA Product Classification

INGREDIENTS (3)

sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
adenosineActive
Quantity: 3 mg in 1 mL
Code: K72T3FS567
Classification: ACTIB
waterInactive
Code: 059QF0KO0R
Classification: IACT

adenosine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code67457-854
Application NumberANDA078686
Product Classification
M
Marketing Category
C73584
G
Generic Name
adenosine
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 20, 2022
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

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