Azithromycin (Page 6 of 6)

16 HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

Azithromycin for injection, USP is supplied in lyophilized form under a vacuum in a

10 mL vial equivalent to 500 mg of azithromycin for intravenous administration. Each vial also contains sodium hydroxide and 413.6 mg citric acid.

Product Code Unit of Sale Strength Each
PRX309810 NDC 63323-398-14 Unit of 10 500 mg per vial NDC 63323-398-41 10 mL single-dose vial

This container closure is not made with natural rubber latex.

Storage

Store the white to off-white lyophilized cake at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. When diluted according to the instructions (1 mg/mL to 2 mg/mL), azithromycin for injection, USP is stable for 24 hours at or below room temperature 30ºC (86ºF), or for 7 days if stored under refrigeration 5ºC (41ºF).

17 PATIENT COUNSELING INFORMATION

Patients should be informed of the following serious and potentially serious adverse reactions that have been associated with azithromycin for injection, USP.

Diarrhea: Inform patients that diarrhea is a common problem caused by antibacterial drugs which usually ends when the antibacterial is discontinued. Sometimes after starting treatment with antibacterials, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibacterial. If this occurs, patients should notify their physician as soon as possible.

The brand names mentioned in this document are the trademarks of their respective owners.

PREMIERProRx ® is a registered trademark of Premier Healthcare Alliance, L.P., used under license.

Manufactured by:

Fresenius Kabi

Lake Zurich, IL 60047

www.fresenius-kabi.com/us

451399A Revised: September 2019

PremierPro Rx Logo
(click image for full-size original)

PACKAGE LABEL — PRINCIPAL DISPLAY — Azithromycin 500 mg Vial Label

NDC 63323-398-41 PRX309810

AZITHROMYCIN FOR INJECTION, USP

500 mg per vial

For Intravenous infusion only

Rx only

PACKAGE LABEL -- PRINCIPAL DISPLAY -- Azithromycin 500 mg Vial Label
(click image for full-size original)

PACKAGE LABEL — PRINCIPAL DISPLAY — Azithromycin 500 mg Vial Tray Label

NDC 63323-398-14 PRX309810

AZITHROMYCIN FOR INJECTION, USP 500 mg per vial

For Intravenous infusion only

To yield 100 mg per mL of solution when reconstituted as directed.

Rx only

10 Vials

PACKAGE LABEL -- PRINCIPAL DISPLAY -- Azithromycin 500 mg Vial Tray Label
(click image for full-size original)
AZITHROMYCIN azithromycin monohydrate injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63323-398
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AZITHROMYCIN MONOHYDRATE (AZITHROMYCIN ANHYDROUS) AZITHROMYCIN ANHYDROUS 500 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM HYDROXIDE
CITRIC ACID MONOHYDRATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63323-398-14 10 VIAL in 1 TRAY contains a VIAL (63323-398-41)
1 NDC:63323-398-41 5 mL in 1 VIAL This package is contained within the TRAY (63323-398-14)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065179 03/20/2006
Labeler — Fresenius Kabi USA, LLC (608775388)
Establishment
Name Address ID/FEI Operations
Fresenius Kabi USA, LLC 023648251 manufacture (63323-398)

Revised: 11/2019 Fresenius Kabi USA, LLC

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