VANCOMYCIN HYDROCHLORIDE (Page 4 of 4)

HOW SUPPLIED/STORAGE AND HANDLING

Vancomycin Hydrochloride for Injection, USP, supplied as follows:

NDC Vancomycin Hydrochloride for Injection, USP Package Factor
31722-210-10 500 mg Vial (equivalent to 500 mg vancomycin) 10 vials per carton
31722-210-32 500 mg Vial (equivalent to 500 mg vancomycin) 25 vials per carton
31722-211-10 1 gram Vial (equivalent to 1 gram vancomycin) 10 vials per carton

Store 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 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.

The brands listed are the trademarks of their respective owners and are not trademarks of Aspiro Pharma Limited.

vancocamber-logo
(click image for full-size original)

Manufactured for:
Camber Pharmaceuticals, Inc.,
Piscataway, NJ 08854

Manufactured by:

aspirologo

Aspiro Pharma Limited
Survey No. 321, Biotech Park, Phase – III
Karkapatla Village, Markook (Mandal) Siddipet Telangana 502281 India.

Revised: 07/2022

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Vancomycin Hydrochloride for Injection, USP (500 mg* per vial) — 10-Vial Label

vanco500mg-viallabel
(click image for full-size original)

Vancomycin Hydrochloride for Injection, USP (500 mg* per vial) — 10-Vial Carton

vanco500mg-vialcarton
(click image for full-size original)

Vancomycin Hydrochloride for Injection, USP (1 g* per vial) — 10-Vial Label

vanco1gm-viallabel
(click image for full-size original)

Vancomycin Hydrochloride for Injection, USP (1 g* per vial) — 10-Vial Carton

vanco1gm-vial-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:31722-210
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:31722-210-32 25 VIAL in 1 CARTON contains a VIAL (31722-210-33)
1 NDC:31722-210-33 10 mL in 1 VIAL This package is contained within the CARTON (31722-210-32)
2 NDC:31722-210-10 10 VIAL in 1 CARTON contains a VIAL (31722-210-33)
2 NDC:31722-210-33 10 mL in 1 VIAL This package is contained within the CARTON (31722-210-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA216591 07/06/2022
VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:31722-211
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:31722-211-10 10 VIAL in 1 CARTON contains a VIAL (31722-211-33)
1 NDC:31722-211-33 20 mL in 1 VIAL This package is contained within the CARTON (31722-211-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA216591 07/06/2022
Labeler — Camber Pharmaceuticals, Inc. (826774775)
Establishment
Name Address ID/FEI Operations
Aspiro Pharma Limited 872341023 manufacture (31722-210), manufacture (31722-211)

Revised: 07/2022 Camber Pharmaceuticals, Inc.

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