Prescription Drug Information: Vancomycin Hydrochloride (Page 3 of 3)

HOW SUPPLIED/STORAGE AND HANDLING

Vancomycin Hydrochloride for Injection, USP is supplied as:

Product Code	Unit of Sale	Strength	Each
PRX22138	NDC 63323-221-48 Unit of 25	500 mg per vial	NDC 63323-221-43
PRX28435	NDC 63323-284-45 Unit of 10	1 gram per vial	NDC 63323-284-41

Prior to reconstitution, the vials may be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

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 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.

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

Manufactured for:

Fresenius Kabi USA, LLC
Lake Zurich, IL 60047

Made in Denmark

www.fresenius-kabi.com/us

451557A
Revised: November 2018

fk-logopremier-logo

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-500mg

VIAL LABEL

NDC 63323-221-43
Vancomycin Hydrochloride for Injection, USP
500 mg* per vial
For intravenous use.
MUST BE FURTHER DILUTED BEFORE USE.
Sterile, Lyophilized.
Preservative free. Rx only.

CARTON

NDC 63323-221-48
Vancomycin Hydrochloride for Injection, USP
500 mg* per vial
For intravenous use.
MUST BE FURTHER DILUTED BEFORE USE.
Preservative free.
25 vials x 500 mg Rx only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-1g

VIAL LABEL

NDC 63323-284-41
Vancomycin Hydrochloride for Injection, USP
1 gram* per vial
For Intravenous Use.
Must be Further Diluted Before Use.
Sterile, Lyophilized.
Preservative free. Rx only.

CARTON

NDC 63323-284-45
Vancomycin Hydrochloride for Injection, USP
1 gram* per vial
For intravenous use.
MUST BE FURTHER DILUTED BEFORE USE.
Preservative free.
10 x 1 g vials Rx only

VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride injection, powder, lyophilized, for solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63323-221 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:63323-221-48 25 VIAL in 1 TRAY contains a VIAL (63323-221-43) 1 NDC:63323-221-43 10 mL in 1 VIAL This package is contained within the TRAY (63323-221-48)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204107 10/26/2017

VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride injection, powder, lyophilized, for solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63323-284 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:63323-284-45 10 VIAL in 1 TRAY contains a VIAL (63323-284-41) 1 NDC:63323-284-41 20 mL in 1 VIAL This package is contained within the TRAY (63323-284-45)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204107 10/26/2017

Labeler — Fresenius Kabi, LLC (608775388)

Establishment
Name	Address	ID/FEI	Operations
Xellia Pharmaceuticals ApS		305814345	manufacture (63323-221), api manufacture (63323-221), label (63323-221), pack (63323-221), analysis (63323-221), manufacture (63323-284), api manufacture (63323-284), label (63323-284), pack (63323-284), analysis (63323-284)

Revised: 12/2022 Fresenius Kabi, LLC