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DOXORUBICIN How Supplied/Storage and Handling (doxorubicin hydrochloride)

16 HOW SUPPLIED/STORAGE AND HANDLING

Doxorubicin Hydrochloride Injection

Doxorubicin Hydrochloride Injection is a sterile, isotonic solution, available in polypropylene (CYTOSAFE)® vials in single vial packs as:

Single-dose Vials

 
10 mg/5 mL (2 mg/mL) NDC 0069-3030-20
 
20 mg/10 mL (2 mg/mL) NDC 0069-3031-20
 
50 mg/25 mL (2 mg/mL) NDC 0069-3032-20

Retain in carton until time of use. Discard unused portion.

Multiple-dose Vials

 
150 mg/75 mL (2 mg/mL) NDC 0069-3033-20
 
200 mg/100 mL (2 mg/mL) NDC 0069-3034-20

Retain in carton until contents are used.

Storage

Store all vials at 2° to 8°C (36° 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 [15° to 30°C (59° to 86°F)] for 2 to 4 hours to return the product to a slightly viscous, mobile solution.

Handling and Disposal

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

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