Calcium Chloride (Page 2 of 2)

HOW SUPPLIED

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

NDC No.	Container	Size	Needle
0409-1631-10	Ansyr™ Plastic Syringe	10 mL	None

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

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.

Hospira, Inc., Lake Forest, IL 60045 USA

LAB-1022-2.0

Revised: 01/2018

PRINCIPAL DISPLAY PANEL — 10 mL Syringe Label

10 mL Single-Dose Syringe — Discard Unused Portion NDC 0409-1631-40

10% Calcium Chloride Injection, USP
1000 mg/10 mL (100 mg/mL)

For Intravenous use only.
2.04 mOsmol/mL (calc.). pH (5.5 to 7.5). Contains no more than 1,000 mcg/L
of aluminum.

Hospira

Distributed by Hospira, Inc., Lake Forest, IL 60045 USA
Rx only

RL-7161

PRINCIPAL DISPLAY PANEL — 10 mL Syringe Carton

10 mL

NDC 0409-1631-40
Rx only

10%
Calcium
Chloride
Injection, USP

1,000 mg/10 mL
(100 mg/mL)

For Intravenous use only

Ansyr^®

Single-Dose Syringe
Discard Unused Portion

Hospira

LOT #####AA
EXP DMMMYYYY

◀ PRESS AND PULL TO OPEN ▶

CALCIUM CHLORIDE calcium chloride injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-1631 Route of Administration INTRAVENOUS DEA Schedule

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

Inactive Ingredients Ingredient Name Strength WATER HYDROCHLORIC ACID SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0409-1631-10 10 CARTON in 1 CONTAINER contains a CARTON (0409-1631-40) 1 NDC:0409-1631-40 1 SYRINGE, PLASTIC in 1 CARTON This package is contained within the CONTAINER (0409-1631-10) and contains a SYRINGE, PLASTIC 1 10 mL in 1 SYRINGE, PLASTIC This package is contained within a CARTON (0409-1631-40) and a CONTAINER (0409-1631-10)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021117 09/14/2005

Labeler — Hospira, Inc. (141588017)

Establishment
Name	Address	ID/FEI	Operations
Hospira, Inc.		093132819	ANALYSIS (0409-1631), MANUFACTURE (0409-1631), PACK (0409-1631), LABEL (0409-1631)

Establishment
Name	Address	ID/FEI	Operations
Hospira Worldwide, LLC		963711309	ANALYSIS (0409-1631)

Revised: 01/2022 Hospira, Inc.