Linezolid labels and packages

Jump to navigation Jump to search
Linezolid
ZYVOX® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Overdosage
Dosage and Administration
How Supplied
Labels and Packages

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

[[File:|800px|thumb]]

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

[[File:|800px|thumb]]

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

[[File:|800px|thumb]]

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

[[File:|800px|thumb]]
[[File:|800px|thumb]]

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

[[File:|800px|thumb]]

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


[[File:|800px|thumb]]

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]


[[File:|800px|thumb]]

References

  1. "ZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY]".

Adapted from the FDA Package Insert.