Adenosine (Page 3 of 3)

REFERENCES

  1. Paul T, Pfammatter J-P. Adenosine: an effective and safe antiarrhythmic drug in pediatrics. Pediatric Cardiology 1997; 18:118-126.

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451005C

Revised: January 2013

PACKAGE LABEL — PRINCIPAL DISPLAY — Adenosine 2 mL Single Dose Vial Label

NDC 63323-651-02

605102

Adenosine Injection, USP

6 mg/2 mL

(3 mg/mL)

For Rapid Bolus Intravenous Use

Usual Dosage: See insert.

Do Not Refrigerate.

2 mL Single Dose Vial

Rx only

605102-vial
(click image for full-size original)

PACKAGE LABEL — PRINCIPAL DISPLAY — Adenosine 2 mL Single Dose Vial Tray Label

NDC 63323-651-02

605102

Adenosine Injection, USP

6 mg/2 mL

(3 mg/mL)

For Rapid Bolus Intravenous Use

Rx only

2 mL Single Dose Vial

605102-tray
(click image for full-size original)

ADENOSINE
adenosine injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63323-651
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ADENOSINE (ADENOSINE) ADENOSINE 3 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 9 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63323-651-02 10 VIAL, SINGLE-USE in 1 TRAY contains a VIAL, SINGLE-USE
1 2 mL in 1 VIAL, SINGLE-USE This package is contained within the TRAY (63323-651-02)
2 NDC:63323-651-04 10 VIAL, SINGLE-USE in 1 TRAY contains a VIAL, SINGLE-USE
2 4 mL in 1 VIAL, SINGLE-USE This package is contained within the TRAY (63323-651-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077133 11/23/2005
Labeler — Fresenius Kabi USA, LLC (608775388)
Establishment
Name Address ID/FEI Operations
Fresenius Kabi USA, LLC 840771732 manufacture (63323-651)

Revised: 10/2019 Fresenius Kabi USA, LLC

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