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AZITHROMYCIN injection, powder, lyophilized, for solution


  1. Patient Information
  2. Diarrhea:
  3. Revised: 11/2014document Id:

Patient Information 

Patients should be informed of the following serious and potentially serious adverse reactions that have been associated with AZITHROMYCIN.

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.

This product's label may have been updated. For current full prescribing information, please visit www.baxter.com

Rx only

Baxter
Manufactured for
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
By: Pfizer Inc, New York, NY 10017

For Product Inquiry 1 800 ANA DRUG (1-800-262-3784)

LAB-0301-10.0

PRINCIPAL DISPLAY PANEL - 1 Vial Label

NDC 10019-648-71

azithromycin
for injection

equivalent to
500 mg/vialof azithromycin
For I.V. infusion only
STERILE

Rx only

Baxter
Mfd. forBaxter Healthcare Corporation
by: Pfizer Inc
NY, NY 10017

PRINCIPAL DISPLAY PANEL - 1 Vial Label

PRINCIPAL DISPLAY PANEL - 10 Vial Carton

NDC 10019-648-02

azithromycin for injection

equivalent to500 mg/vialof azithromycin
To yield 100 mg/mL* of solution when reconstituted as directed
For I.V. infusion only
STERILE

Rx only

10 Vials

Baxter
Manufactured for
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
by: Pfizer Inc
NY, NY 10017
MADE IN IRELAND

PRINCIPAL DISPLAY PANEL - 10 Vial Carton
AZITHROMYCIN
azithromycin injection, powder, lyophilized, for solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:10019-648
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AZITHROMYCIN DIHYDRATE(UNII: 5FD1131I7S) (AZITHROMYCIN ANHYDROUS - UNII:J2KLZ20U1M)AZITHROMYCIN ANHYDROUS100 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10019-648-0210 in 1 BOX
15 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDA AUTHORIZED GENERICNDA05073301/01/1997
Labeler -Baxter Healthcare Corporation (005083209)
Registrant -Pfizer Inc (113480771)
Establishment
NameAddressID/FEIBusiness Operations
Pfizer Ireland Pharmaceuticals896090987API MANUFACTURE(10019-648)
Establishment
NameAddressID/FEIBusiness Operations
Pharmacia and Upjohn Company LLC829076566API MANUFACTURE(10019-648) , MANUFACTURE(10019-648)

Revised: 11/2014document Id: 

c9cf5e72-5b34-4ed4-9fe0-fda76921fd89Set id: 65d8adaa-04c8-4c5e-ae57-2fbae0979178Version: 7Effective Time: 20141119Baxter Healthcare Corporation



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