(doxorubicin hydrochloride)

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How Supplied/Storage and Handling

16 HOW SUPPLIED/STORAGE AND HANDLING

Doxorubicin Hydrochloride Injection, is available as follows:

Doxorubicin Hydrochloride Injection is a sterile, isotonic solution, available in single-dose polypropylene (CYTOSAFE)® vials, and multiple-dose polypropylene (CYTOSAFE)® vials:

Unit of Sale

Total Strength/Total Volume

(Concentration)

NDC 0069-3030-20

Carton of 1 Single-dose Vial

10 mg/5 mL

(2 mg/mL)

NDC 0069-3031-20

Carton of 1 Single-dose Vial

20 mg/10 mL

(2 mg/mL)

NDC 0069-3032-20

Carton of 1 Single-dose Vial

50 mg/25 mL

(2 mg/mL)

NDC 0069-3033-20

Carton of 1 Multiple-dose Vial

150 mg/75 mL

(2 mg/mL)

NDC 0069-3034-20

Carton of 1 Multiple-dose Vial

200 mg/100 mL

(2 mg/mL)

Retain in carton until contents are used. For single-dose vials, discard unused portion.

Doxorubicin Hydrochloride Injection is a sterile, isotonic solution, available in single-dose ONCO-TAIN® glass vials, and multiple-dose ONCO-TAIN® glass vials:

Unit of Sale

Total Strength/Total Volume

(Concentration)

NDC 0069-0358-20

Carton of 1 Single-dose Vial

10 mg/5 mL

(2 mg/mL)

NDC 0069-0277-02

Carton of 1 Single-dose Vial

20 mg/10 mL

(2 mg/mL)

NDC 0069-0343-02

Carton of 1 Single-dose Vial

50 mg/25 mL

(2 mg/mL)

NDC 0069-1542-20

Carton of 1 Multiple-dose Vial

200 mg/100 mL

(2 mg/mL)

ONCO-TAIN® is the vial external protection system.

Retain in carton until contents are used. For single-dose ONCO-TAIN® glass vials, discard unused portion.

Storage

Store all vials at 2°C to 8°C (36°F to 46°F). Protect from light.

Storage of Doxorubicin Hydrochloride Injection under refrigerated conditions can result in the formation of a gelled product. Place gelled product at room temperature [15ºC to 30ºC (59ºF to 86ºF)] for 2 to 4 hours to return the product to a slightly viscous, mobile solution.

Handling and Disposal

Doxorubicin Hydrochloride Injection is a hazardous drug. Follow applicable special handling and disposal procedures.1

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