Prescription Drug Information: Vancomycin Hydrochloride (Page 4 of 4)

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 per 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.

meitheal®

Mfd. for Meitheal Pharmaceuticals
Chicago, IL 60631 (USA)
©2022 Meitheal Pharmaceuticals Inc.


Mfd. by Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.Nanjing, China 210061

May 2022

810152-00

PRINCIPAL DISPLAY PANEL – Vancomycin Hydrochloride for Injection, USP 5 gram Container Label

NDC 71288-025 -75

Rx Only

Vancomycin Hydrochloride for Injection, USP

5 grams* per Pharmacy Bulk Package

PHARMACY BULK PACKAGE — NOT FOR DIRECT INFUSION

For Intravenous Infusion

MUST BE FURTHER DILUTED BEFORE USE

pdp-5g-vial
(click image for full-size original)

PRINCIPAL DISPLAY PANEL – Vancomycin Hydrochloride for Injection, USP 5 gram Carton

NDC 71288-025 -75

1 Pharmacy Bulk Package Bottle

Rx Only

Vancomycin Hydrochloride for Injection, USP

5 grams* per Pharmacy Bulk Package

PHARMACY BULK PACKAGE — NOT FOR DIRECT INFUSION

For Intravenous Infusion

MUST BE FURTHER DILUTED AFTER RECONSTITUTION AND BEFORE INFUSION. NOT TO BE DISPENSED AS A UNIT.

pdp-5g-carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL – Vancomycin Hydrochloride for Injection, USP 10 gram Container Label

NDC 71288-026 -75

Rx Only

Vancomycin Hydrochloride for Injection, USP

10 grams* per Pharmacy Bulk Package

PHARMACY BULK PACKAGE — NOT FOR DIRECT INFUSION

For Intravenous Infusion

MUST BE FURTHER DILUTED BEFORE USE

pdp-10g-vial
(click image for full-size original)

PRINCIPAL DISPLAY PANEL – Vancomycin Hydrochloride for Injection, USP 10 gram Carton

NDC 71288-026 -75

1 Pharmacy Bulk Package Bottle

Rx Only

Vancomycin Hydrochloride for Injection, USP

10 grams* per Pharmacy Bulk Package

PHARMACY BULK PACKAGE — NOT FOR DIRECT INFUSION

For Intravenous Infusion

MUST BE FURTHER DILUTED AFTER RECONSTITUTION AND BEFORE INFUSION. NOT TO BE DISPENSED AS A UNIT.

pdp-10g-carton
(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:71288-025
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN) VANCOMYCIN 5 g in 100 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71288-025-75 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON contains a VIAL, PHARMACY BULK PACKAGE
1 100 mL in 1 VIAL, PHARMACY BULK PACKAGE This package is contained within the CARTON (71288-025-75)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA215196 07/27/2022
VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71288-026
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN) VANCOMYCIN 10 g in 95 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71288-026-75 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON contains a VIAL, PHARMACY BULK PACKAGE
1 95 mL in 1 VIAL, PHARMACY BULK PACKAGE This package is contained within the CARTON (71288-026-75)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA215196 07/27/2022
Labeler — Meitheal Pharmaceuticals Inc. (080548348)

Revised: 08/2022 Meitheal Pharmaceuticals Inc.

Page 4 of 4 1 2 3 4

RxDrugLabels.com provides trustworthy package insert and label information about marketed prescription drugs as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by RxDrugLabels.com. Every individual prescription drug label and package insert entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

As a leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. RxDrugLabels.com provides the full prescription-only subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2022. All Rights Reserved.