Vancomycin Hydrochloride: Package Insert and Label Information (Page 3 of 3)

Storage Conditions

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Sterile, Nonpyrogenic, Preservative-free, Lyophilized.

The container closure is not made with natural rubber latex.

ANIMAL PHARMACOLOGY

In animal studies, hypotension and bradycardia occurred in dogs receiving an intravenous infusion of vancomycin hydrochloride 25 mg/kg, at a concentration of 25 mg/mL and an infusion rate of 13.3 mL/min.

REFERENCES

  1. Moellering RC, Krogstad DJ, Greenblatt DJ: Vancomycin therapy in patients with impaired renal function: A nomogram for dosage. Ann Inter Med 1981; 94:343.

Brands listed are the trademarks of their respective owners.

Athenex

Mfd. for Athenex
Schaumburg, IL 60173 (USA)
Made in India
©2018 Athenex.

Revised: February 2018

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Vial Label

NDC 70860-104-41

Vancomycin Hydrochloride for Injection, USP

500 mg per vial

Rx only

For Intravenous Use

MUST BE FURTHER DILUTED BEFORE USE, SEE INSERT

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Vial Label
(click image for full-size original)

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Vial Label

NDC 70860-105-41

Vancomycin Hydrochloride for Injection, USP

1 gram per vial

Rx only

For Intravenous Use

MUST BE FURTHER DILUTED BEFORE USE, SEE INSERT

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Vial Label
(click image for full-size original)
VANCOMYCIN HYDROCHLORIDE
vancomycin hydrochloride injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70860-104
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
vancomycin hydrochloride (vancomycin) vancomycin 500 mg in 10 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70860-104-10 10 VIAL in 1 CARTON contains a VIAL (70860-104-41)
1 NDC:70860-104-41 10 mL in 1 VIAL This package is contained within the CARTON (70860-104-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205694 01/01/2017
VANCOMYCIN HYDROCHLORIDE
vancomycin hydrochloride injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70860-105
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
vancomycin hydrochloride (vancomycin) vancomycin 1 g in 20 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70860-105-20 10 VIAL in 1 CARTON contains a VIAL (70860-105-41)
1 NDC:70860-105-41 20 mL in 1 VIAL This package is contained within the CARTON (70860-105-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205694 01/01/2017
Labeler — Athenex Pharmaceutical Division, LLC. (080318964)

Revised: 12/2018 Athenex Pharmaceutical Division, LLC.

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