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AZITHROMYCIN- azithromycin monohydrate injection, powder, lyophilized, for solution


  1. Patient Information
  2. Diarrhea:
  3. Revised: 9/2019document Id:

Patient 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.

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Lake Zurich, IL 60047

www.fresenius-kabi.com/us

45996J

Revised: September 2019

PACKAGE LABEL - PRINCIPAL DISPLAY - Azithromycin 500 mg Vial Label

NDC63323-398-01

309810

AZITHROMYCIN FOR INJECTION, USP

500 mg per vial

For Intravenous infusion only

Rx only

PACKAGE LABEL - PRINCIPAL DISPLAY - Azithromycin 500 mg Vial Label

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

NDC63323-398-10

309810

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
AZITHROMYCIN
azithromycin monohydrate injection, powder, lyophilized, for solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63323-398
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AZITHROMYCIN MONOHYDRATE(UNII: JTE4MNN1MD) (AZITHROMYCIN ANHYDROUS - UNII:J2KLZ20U1M)AZITHROMYCIN ANHYDROUS500 mg in 5 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM HYDROXIDE(UNII: 55X04QC32I)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63323-398-1010 in 1 TRAY03/20/2006
1NDC:63323-398-015 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA06517903/20/2006
Labeler -Fresenius Kabi USA, LLC (608775388)
Establishment
NameAddressID/FEIBusiness Operations
Fresenius Kabi USA, LLC023648251manufacture(63323-398)

Revised: 9/2019document Id: 

93f29c3d-b3ae-7ed2-e053-2a95a90af017Set id: b69917c0-95d5-4b29-b0e3-07054a4fd79fVersion: 7Effective Time: 20190930Fresenius Kabi USA, LLC



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