Calcium Chloride

Manufacturer
A-S Medication Solutions
Effective date
2018-01-23
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 01:03:54

Label at a glance#

ProductCalcium Chloride
Active ingredientCALCIUM CHLORIDE
Label structure9 sections

Indications and uses

Calcium Chloride Injection, USP, 10% is indicated: In the treatment of hypocalcemia in conditions requiring a prompt increase in plasma calcium levels (e.g., neonatal tetany and tetany due to parathyroid deficiency, vitamin D deficiency and alkalosis) and for prevention of hypocalcemia during exchange transfusions. As adjunctive therapy in the management of acute symptoms in lead colic. In the treatment of magnesi...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

CALCIUM CHLORIDE
INJECTION, USP, 10%

13.6 mEq (1 g) per 10 mL
100 mg (1.36 mEq)/ mL
Osmolarity approximately 2050 mOsmol/L

DESCRIPTION

DESCRIPTION SECTION

Calcium Chloride Injection, USP, 10%, is a sterile aqueous solution containing, in each mL, 100 mg (1.36 mEq) calcium chloride. The pH of the solution may have been adjusted with hydrochloric acid and / or calcium hydroxide, when necessary. The air above the liquid in the individual containers has been displaced by flushing with nitrogen during the filling operation. The preparation contains no antimicrobial preservatives and is intended as a single-dose vial; once the unit is assembled and used, any remaining portion of the solution must be discarded with the entire unit.

Calcium Chloride, USP, contains two molecules of water of hydration and is chemically designated as CaCl2 • 2H20.

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

Calcium is the fifth most abundant element in the body, the major fraction of which is found in the bony structure. Calcium plays important physiological roles; it is essential for the functional integrity of the nervous and muscular systems; it is necessary for normal cardiac function; and it is one of the factors involved in the mechanism of blood coagulation.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Calcium Chloride Injection, USP, 10% is indicated:

In the treatment of hypocalcemia in conditions requiring a prompt increase in plasma calcium levels (e.g., neonatal tetany and tetany due to parathyroid deficiency, vitamin D deficiency and alkalosis) and for prevention of hypocalcemia during exchange transfusions.

As adjunctive therapy in the management of acute symptoms in lead colic.

In the treatment of magnesium intoxication due to overdosage of magnesium sulfate.

In severe hyperkalemia, to combat deleterious effects on electrocardiographic (ECG) function, pending correction of the potassium level in the extracellular fluid.

In cardiac resuscitation, particularly after open heart surgery, when epinephrine fails to improve weak or ineffective myocardial contractions.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Calcium chloride is contraindicated for cardiac resuscitation in the presence of ventricular fibrillation.

WARNINGS

WARNINGS SECTION

Calcium chloride should be injected into a large vein very slowly, as it may cause peripheral vasodilatation and a cutaneous burning sensation. A moderate fall in blood pressure due to vasodilatation may attend the injection. Since calcium chloride is an acidifying salt, it is usually undesirable in the treatment of hypocalcemia or renal insufficiency.

PRECAUTIONS

PRECAUTIONS SECTION

General

GENERAL PRECAUTIONS SECTION

Calcium Chloride Injection, USP, 10% is irritating to veins and must not be injected into tissues, since severe necrosis and sloughing may occur. Great care should be taken to avoid extravasation or accidental injection into perivascular tissues.

Solutions should be warmed to body temperature. Injections should be made slowly through a small needle into a large vein to minimize venous irritation and avoid undesirable reactions. It is particularly important to prevent a high concentration of calcium from reaching the heart because of the danger of cardiac syncope. If injected into the ventricular cavity in cardiac resuscitation care must be taken to avoid injection into the myocardial tissue.

Drug Interactions

DRUG INTERACTIONS SECTION

Because of the danger involved in the simultaneous use of calcium salts and drugs of the digitalis group, a digitalized patient should not receive an intravenous injection of a calcium compound unless the indications are clearly defined.

Calcium salts should not generally be mixed with carbonates, phosphates, sulfates or tartrates in parenteral admixtures.

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

Rapid I.V. injection may cause the patient to complain of tingling sensations, a calcium taste, a sense of oppression or “heat wave.”

Injections of calcium chloride are accompanied by peripheral vasodilation as well as a local “burning” sensation, and there may be a moderate fall in blood pressure.

DOSAGE AND ADMINISTRATIONFOR INTRACARDIAC OR INTRAVENOUS USE ONLY

DOSAGE & ADMINISTRATION SECTION

INJECT SLOWLY
Calcium Chloride Injection, USP, 10%, is administered only by slow intravenous injection (not to exceed 1 mL/min) and / or in cardiac resuscitation, by injection into the ventricular cavity. It must not be injected into the myocardium.

The usual precautions for intravenous therapy should be observed. If time permits, the solution should be warmed to body temperature. The injection should be halted if the patient complains of any discomfort; it may be resumed when symptoms disappear. Following injection, the patient should remain recumbent for a short time.

INTRACARDIAC USE
For cardiac resuscitation, inject into the ventricular cavity, not into the heart muscle.

Usual Adult Dosage: 200 to 800 mg (2 to 8 mL) when injected into the ventricular cavity.

Pediatric Dosage: 0.2 mL/kg of body weight.

INTRAVENOUS USE
Hypocalcemic Disorders

Usual Adult Dosage: 500 mg to 1 g (5 to 10 mL) at intervals of 1 to 3 days, depending on the response of the patient and / or results of serum calcium determinations. Repeated injections may be required because of rapid excretion of calcium.

Pediatric Dosage: 0.2 mL /kg of body weight. Maximum 1-10 mL/day.

Magnesium Intoxication
Initial Adult Dose: 500 mg (5 mL) administered promptly and the patient observed for signs of recovery before further doses are given.

Hyperkalemic ECG Disturbances of Cardiac Function
Dosage should be adjusted by constant monitoring of ECG changes during administration.

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-2361

NDC: 50090-2361-0 10 mL in a SYRINGE

Calcium Chloride

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2361-0ML - Milliliter50090-23619cc096d5-e180-4860-80d5-6b53afca284a12019-02-13
76329-3304-1ML - Milliliter76329-330465d97f45-431e-4b7a-98cc-29afd8b898c212013-02-13

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50090-236150090-2361-0
76329-3304

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203477-001CALCIUM CHLORIDE 10%CALCIUM CHLORIDE100MG/MLINJECTABLE / INJECTIONAP2018-05-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A203477-001AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-0984e616aacf4f…
2026-08-18 06:07:402026-07A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-09bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-09782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-0987673890dc5c…
2021-03-12 10:30 UTC2021-03A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-095aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-098869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-09c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-093f01610625f2…
2019-09-15 20:21 UTC2019-09A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-09b00525d2431f…
2019-07-19 19:46 UTC2019-07A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-09ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-096a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-091c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-09ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-09a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-099b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-09a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-093f0d92c62455…
2023-05-13 08:27 UTC2023-05A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-09053a50430f4f…
2023-01-26 05:58 UTC2023-01A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-093bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-093a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203477-001CALCIUM CHLORIDE 10%100MG/MLINJECTABLE / INJECTIONAP2018-05-09f41ea6bd6efb…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A203477-001AP184e616aacf4f…
2026-08-18 06:07:402026-07A203477-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203477-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203477-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203477-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203477-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203477-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203477-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203477-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203477-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203477-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203477-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203477-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203477-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203477-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203477-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203477-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203477-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203477-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203477-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203477-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203477-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203477-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A203477-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203477-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203477-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203477-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A203477-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A203477-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203477-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203477-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203477-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203477-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203477-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203477-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203477-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A203477-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A203477-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203477-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203477-001AP1f41ea6bd6efb…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Calcium ChlorideCALCIUM CHLORIDEInternational Medication Systems, Limited8295039b-2559-4626-90c8-6ac7e896e41a2024-03-01Warnings, Adverse reactionsExact identifier
ndc (product): 76329-3304
546ed170-7bb2-48bd-a97b-7c0e98c0a20a958ff1a4-34f4-45ff-9b36-fa851d3abbed2018-01-23Warnings, Adverse reactionsExact identifier
spl id: 546ed170-7bb2-48bd-a97b-7c0e98c0a20a
spl set id: 958ff1a4-34f4-45ff-9b36-fa851d3abbed

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.