Adenosine

Adenosine

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

Company

DUNS: 918601238

Effective Date

December 4, 2017

Labeling Type

Human Prescription Drug Label

Active Ingredients

Adenosine(3 mg in 1 mL)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Labeler

Gland Pharma Limited

DUNS Number

918601238

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

68083-101

Application Number

ANDA077283

Marketing Category

ANDA (C73584)

Route of Administration

INTRAVENOUS

Effective Date

December 4, 2017

Ingredients

sodium chlorideInactive

Code: 451W47IQ8XClass: IACT

waterInactive

Code: 059QF0KO0RClass: IACT

Code: K72T3FS567Class: ACTIBQuantity: 3 mg in 1 mL