Calcium Chloride (Page 2 of 2)

HOW SUPPLIED

10% Calcium Chloride Injection, USP is supplied in single-dose containers as follows:

NDC No.	Stock No.	Container Size	Needle
76329-3304-1	3304	10 mL	None

One shrink wrapped package containing 10 unit cartons, each containing a Luer-Jet™ Luer-Lock Prefilled Syringe.
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Syringe Assembly Directions:

USE ASEPTIC TECHNIQUE

Do not assemble until ready to use.

*CAUTION: IMPROPER ENGAGING MAY CAUSE GLASS BREAKAGE AND SUBSEQUENT INJURY.

CLINICAL STUDIES

Medical literature also refers to the administration of calcium chloride in the treatment of magnesium intoxication due to overdosage of magnesium sulfate, and to combat the deleterious effects of hyperkalemia as measured by electrocardiogram (ECG), pending correction of the increased potassium level in the extracellular fluid. However, adequate well-controlled, randomized clinical studies have not been done to support these indications.

Printed in USA
© International Medication Systems, Limited 2019

International Medication Systems, Ltd. Rev. 2-19
South El Monte, CA 91733 USA
An Amphastar Pharmaceuticals Company

6933040G

10% Calcium Chloride Injection, USP — Carton

Luer-Lock Prefilled Syringe

NDC 76329-3304-1

10% Calcium Chloride
Injection, USP
1 g/10 mL (100 mg/mL)
(1.4 mEq/mL)

Rx only

FOR SLOW INTRAVENOUS USE

Single dose. Discard unused portion.

10 mL Single Dose LUER-JET^TM LUER-LOCK Prefilled Syringe

CALCIUM CHLORIDE calcium chloride injection

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76329-3304 Route of Administration INTRAVENOUS, INTRAVENTRICULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM CHLORIDE (CALCIUM CATION) CALCIUM CHLORIDE 100 mg in 1 mL

Inactive Ingredients Ingredient Name Strength Hydrochloric Acid SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:76329-3304-1 10 SYRINGE in 1 PACKAGE contains a SYRINGE 1 10 mL in 1 SYRINGE This package is contained within the PACKAGE (76329-3304-1)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA203477 07/08/2018

Labeler — International Medication Systems, Limited (055750020)

Establishment
Name	Address	ID/FEI	Operations
International Medication Systems, Limited		055750020	analysis (76329-3304), manufacture (76329-3304), label (76329-3304)

Revised: 12/2021 International Medication Systems, Limited