Linezolid labels and packages: Difference between revisions
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==Labels And Packages== | ==Labels And Packages== | ||
PRINCIPAL DISPLAY PANEL - 100 mL Bag Label | |||
NDC 0009-5137-01 | NDC 0009-5137-01 | ||
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PRINCIPAL DISPLAY PANEL - 300 mL Bag Label | |||
NDC 0009-5140-01 | NDC 0009-5140-01 | ||
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PRINCIPAL DISPLAY PANEL - 600 mg Tablet Bottle Label | |||
NDC 0009-5135-02 | NDC 0009-5135-02 | ||
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PRINCIPAL DISPLAY PANEL - 600 mL Blister Pack | |||
Zyvox® | Zyvox® | ||
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PRINCIPAL DISPLAY PANEL - 600 mg Tablet Bottle Carton | |||
UNIT DOSE | UNIT DOSE | ||
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PRINCIPAL DISPLAY PANEL - 150 mL Bottle Label | |||
NDC 0009-5136-01 | NDC 0009-5136-01 | ||
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PRINCIPAL DISPLAY PANEL - 150 mL Bottle Carton | |||
NDC 0009-5136-01 | NDC 0009-5136-01 | ||
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==References== | ==References== | ||
Latest revision as of 04:41, 9 January 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]
Labels And Packages
PRINCIPAL DISPLAY PANEL - 100 mL Bag Label
NDC 0009-5137-01 Rx only ZYVOX® (linezolid) injection
200 mg/100 mL
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Do not freeze. Each mL contains: linezolid 2 mg dextrose, USP 50.24 mg sodium citrate, USP 1.64 mg citric acid, USP 0.85 mg water for injection, USP qs pH adjusted to 4.8 with sodium hydroxide or hydrochloric acid. Sterile and nonpyrogenic Single dose container. Do not add supplementary medication. Do not use in series connections. 817 988 202 LOT
For intravenous administration Check for leaks by squeezing container. If leaks are found, discard, as sterility may be impaired. Check linezolid solution for clarity; it may exhibit a yellow color that intensifies over time, with no adverse effect on potency. DOSAGE AND USE: See accompanying prescribing information. MADE IN NORWAY Mfd. by Fresenius Kabi Norge AS NO-1753 Halden, Norway Pfizer Distributed by: Pharmacia & Upjohn Co Division of Pfizer Inc, NY, NY 10017 7 OTHER
1234567890 FUU 0701 01-68-26-019
EXP
free flex
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PRINCIPAL DISPLAY PANEL - 300 mL Bag Label
NDC 0009-5140-01 Rx only ZYVOX® (linezolid) injection
600 mg/300 mL
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Do not freeze. Each mL contains: linezolid 2 mg dextrose, USP 50.24 mg sodium citrate, USP 1.64 mg citric acid, USP 0.85 mg water for injection, USP qs
pH adjusted to 4.8 with sodium hydroxide or hydrochloric acid. Sterile and nonpyrogenic Single dose container.
817 999 303
LOT
Do not add supplementary medication. Do not use in series connections. For intravenous administration Check for leaks by squeezing container. If leaks are found, discard, as sterility may be impaired. Check linezolid solution for clarity; it may exhibit a yellow color that intensifies over time, with no adverse effect on potency. DOSAGE AND USE: See accompanying prescribing information. MADE IN NORWAY Mfd. by Fresenius Kabi Norge AS NO-1753 Halden, Norway Pfizer Distributed by: Pharmacia & Upjohn Co Division of Pfizer Inc, NY, NY 10017 7 OTHER
EXP
freeflex 123456789 FUU 0703 01-68-26-020
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PRINCIPAL DISPLAY PANEL - 600 mg Tablet Bottle Label
NDC 0009-5135-02
20 Tablets Rx only
ZYVOX® (linezolid) tablets
600 mg
Pfizer Distributed by Pharmacia & Upjohn Co Division of Pfizer Inc, NY, NY 10017
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PRINCIPAL DISPLAY PANEL - 600 mL Blister Pack
Zyvox® (linezolid) tablets 600 mg Distributed by Pharmacia & Upjohn Co Division of Pfizer Inc, NY, NY 10017 MADE IN SINGAPORE
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PRINCIPAL DISPLAY PANEL - 600 mg Tablet Bottle Carton
UNIT DOSE
Pfizer NDC 0009-5135-03
Zyvox® (linezolid)
600 mg
tablets
For in-institution use only
30 Tablets Rx only
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PRINCIPAL DISPLAY PANEL - 150 mL Bottle Label
NDC 0009-5136-01
150 mL (when constituted) Rx only
ZYVOX®
(linezolid) for oral suspension
100 mg/5 mL
Pfizer Distributed by Pharmacia & Upjohn Co Division of Pfizer Inc, NY, NY 10017
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PRINCIPAL DISPLAY PANEL - 150 mL Bottle Carton
NDC 0009-5136-01 150 mL (when constituted) Rx only
ZYVOX®
(linezolid) for oral suspension
100 mg/5 mL
Pfizer Distributed by Pharmacia & Upjohn Co Division of Pfizer Inc, NY, NY 10017[1]
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References
Adapted from the FDA Package Insert.