16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
Docetaxel Injection, USP is supplied in single-dose or multiple-dose vials as a sterile, pyrogen-free, non-aqueous colorless to pale yellow solution. Discard unused portion of the single-dose vial.
The following strengths are available in a one-vial formulation:
Unit of Sale | Concentration |
NDC 0409-0201-02 Carton of 1 single-dose vial | 20 mg/2 mL (10 mg/mL) |
NDC 0409-0201-10 Carton of 1 multiple-dose vial | 80 mg/8 mL (10 mg/mL) |
NDC 0409-0201-20 Carton of 1 multiple-dose vial | 160 mg/16 mL (10 mg/mL) |
16.2 Storage
Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature]. Retain in the original package to protect from light. Freezing does not adversely affect the product.
After first use and following multiple needle entries and product withdrawals, Docetaxel Injection multiple-dose vials are stable for up to 28 days when stored between 2°C and 8°C (36°F and 46°F) and protected from light.
16.3 Handling and Disposal
Docetaxel Injection is a hazardous drug. Follow applicable special handling and disposal procedures.1