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ZYVOX® (linezolid) How Supplied/Storage and Handling


16.1 Injection

ZYVOX I.V. Injection is available in single-use, ready-to-use flexible plastic infusion bags in a foil laminate overwrap. The infusion bags and ports are latex-free. The infusion bags are available in the following package sizes:

100 mL bag (200 mg linezolid) NDC 0009-5137-01
100 mL bag (200 mg linezolid) × 10 NDC 0009-5137-04
300 mL bag (600 mg linezolid) NDC 0009-5140-01
300 mL bag (600 mg linezolid) × 10 NDC 0009-5140-04

16.2 Tablets

ZYVOX Tablets are available as follows:

600 mg (white, capsule-shaped, film-coated tablets printed with "ZYVOX 600 mg")

100 tablets in HDPE bottle NDC 0009-5135-01
20 tablets in HDPE bottle NDC 0009-5135-02
Unit dose packages of 30 tablets NDC 0009-5135-03

600 mg (white, capsule-shaped, film-coated tablets debossed with "ZYV" on one side and "600" on the other)

20 tablets in HDPE bottle NDC 0009-5138-02
Unit dose packages of 30 tablets NDC 0009-5138-03

16.3 Oral Suspension

ZYVOX for Oral Suspension is available as a dry, white to off-white, orange-flavored granule/powder. When constituted as directed, each bottle will contain 150 mL of a suspension providing the equivalent of 100 mg of linezolid per each 5 mL. ZYVOX for Oral Suspension is supplied as follows:

100 mg/5 mL in 240-mL glass bottles NDC 0009-5136-01

16.4 Storage and Handling

Store at 25°C (77°F). Protect from light. Keep bottles tightly closed to protect from moisture. It is recommended that the infusion bags be kept in the overwrap until ready to use. Each overwrap contains a peel-off label. Apply the peel- off label to the infusion bag for barcode scanning before use. Protect infusion bags from freezing.

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