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PRECEDEX How Supplied/Storage and Handling (dexmedetomidine hydrochloride injection)

16 HOW SUPPLIED/STORAGE AND HANDLING

Precedex Injection

Precedex (dexmedetomidine hydrochloride) injection 200 mcg/2 mL (100 mcg/mL) is available in 2 mL clear glass vials. The strength is based on the dexmedetomidine base. Vials are intended for single use only.

NDC No.

Container

Size

0409-1638-02

Vial

2 mL

Precedex in 0.9% Sodium Chloride Injection

Precedex (dexmedetomidine hydrochloride in 0.9% Sodium Chloride) injection is available as 80 mcg/20 mL (4 mcg/mL), 200 mcg/50 mL (4 mcg/mL) and 400 mcg/100 mL (4 mcg/mL) in 20 mL clear glass vials, 50 mL and 100 mL clear glass bottles, respectively. Containers are intended for single use only.

NDC No.

Container

Size

0409-1660-20

Vial

20 mL

0409-1660-50

Bottle

50 mL

0409-1660-10

Bottle

100 mL

Store at controlled room temperature, 25°C (77°F) with excursions allowed from 15 to 30°C (59 to 86°F). [See USP.]

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