Calcium Chloride

Manufacturer
Hospira, Inc.
Effective date
2026-02-02
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
21
Source
full-release
Hydrated at
2026-05-31 21:58:46

Label at a glance#

ProductCalcium Chloride
Active ingredientCALCIUM CHLORIDE
Label structure16 sections

Indications and uses

Calcium Chloride Injection is indicated for the treatment of adult and pediatric patients with acute symptomatic hypocalcemia. Limitations of Use The safety and effectiveness of Calcium Chloride Injection for long-term use has not been established.

Dosage and administration

      Administer Calcium Chloride Injection by slow intravenous infusion in a central or deep vein in adults and pediatric patients (with or without renal impairment); do not administer by bolus [see Warnings and Precautions (5.2 , 5.4) ] . The maximum recommended infusion rate is 1 mL/minute (100 mg/minute). Additional important administration instructions regarding Calcium Chloride Injection are as follows: • Do...

Storage and handling

Calcium Chloride Injection, USP (clear solution) is supplied in single-dose syringes as follows: Unit of Sale and Product Description Strength NDC Bundle of 10 10 mL Ansyr ® Plastic Syringe 10% (1,000 mg/10 mL) (100 mg/mL) 0409-1631-10 The 100 mg/mL concentration represents 27 mg or 1.4 mEq of elemental calcium per mL of solution. Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59...

Label contents#

Full prescribing information#

1 INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Calcium Chloride Injection is indicated for the treatment of adult and pediatric patients with acute symptomatic hypocalcemia.

Limitations of Use

The safety and effectiveness of Calcium Chloride Injection for long-term use has not been established.

2 DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

     

2.1 Important Administration Instructions

SPL UNCLASSIFIED SECTION

Administer Calcium Chloride Injection by slow intravenous infusion in a central or deep vein in adults and pediatric patients (with or without renal impairment); do not administer by bolus [see Warnings and Precautions (5.2, 5.4)]. The maximum recommended infusion rate is 1 mL/minute (100 mg/minute).

Additional important administration instructions regarding Calcium Chloride Injection are as follows:

  • Do not use intramuscularly or subcutaneously to avoid tissue necrosis calcinosis cutis [see Warnings and Precautions (5.4)].
  • Visually inspect for particulate matter and discoloration prior to administration (the solution is clear, and the seal is intact). Do not administer if the solution is unclear or the seal is not intact.
  • Stop the administration if the patient complains of any administration-related discomfort; administration may be resumed when symptoms disappear.
  • Discard the unused portion.
  • If time permits, allow the solution to warm to body temperature.

2.4 Drug Incompatibilities

SPL UNCLASSIFIED SECTION

Do not mix Calcium Chloride Injection with other drugs simultaneously. Do not mix Calcium Chloride Injection with ceftriaxone or administer these products simultaneously via a Y-site because concurrent use can lead to the formation of ceftriaxone-calcium precipitates [see Warnings and Precautions (5.1)]:

  • In neonates (28 days of age or younger), concomitant use of Calcium Chloride Injection and ceftriaxone is contraindicated [see Contraindications (4)].
  • In patients older than 28 days of age, ceftriaxone and calcium-containing products may be administered sequentially, provided the infusion lines are thoroughly flushed between infusions with a compatible fluid.

3 DOSAGE FORMS AND STRENGTHS

DOSAGE FORMS & STRENGTHS SECTION

Calcium Chloride Injection, USP (single-dose) supplied as:

  • 10% (1,000 mg/10 mL) (100 mg/mL) in an Ansyr® Plastic Syringe

The 100 mg/mL concentration represents 27 mg or 1.4 mEq of elemental calcium per mL of solution.

4 CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Calcium Chloride Injection is contraindicated in:

  • Patients with ventricular fibrillation
  • Patients with asystole and electromechanical dissociation

Newborns (up to 28 days of age) if they require (or are expected to require) ceftriaxone intravenous treatment because of the risk of precipitation of ceftriaxone-calcium, regardless of whether these products would be received at different times or through separate intravenous lines [see Warnings and Precautions (5.1)].

5 WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS SECTION

     

5.1 End-Organ Damage due to Intravascular Ceftriaxone-Calcium Precipitates

SPL UNCLASSIFIED SECTION

The use of Calcium Chloride Injection is contraindicated in newborns (up to 28 days of age) if they require (or are expected to require) ceftriaxone intravenous treatment because of the risk of precipitation of ceftriaxone-calcium, regardless of whether these products would be received at different times or through separate intravenous lines [see Contraindications (4)]. Cases of fatal reactions with calcium-ceftriaxone precipitates in lungs and kidneys in premature and full-term newborns aged less than 1 month have occurred when ceftriaxone and calcium were administered either simultaneously or non-simultaneously and through different intravenous lines. In-vitro studies demonstrated that neonates have an increased risk of precipitation of ceftriaxone-calcium compared to other age groups.

In patients older than 28 days of age, Calcium Chloride Injection and ceftriaxone intravenous solutions may be administered sequentially one after another if infusion lines at different sites are used, infusion lines are replaced, or infusion lines are thoroughly flushed between infusions with physiological salt solution to avoid precipitation. Do not mix or administer Calcium Chloride Injection simultaneously with ceftriaxone, even if using different infusion lines or different infusion sites as it can lead to precipitation of ceftriaxone-calcium [see Dosage and Administration (2.4)].

5.2 Hypotension, Bradycardia, Arrhythmias, and Syncope with Rapid Administration

SPL UNCLASSIFIED SECTION

Rapid injection of Calcium Chloride Injection may cause vasodilation, decreased blood pressure, bradycardia, arrhythmias, syncope, and cardiac arrest. It is particularly important to prevent a high concentration of calcium from reaching the heart because of the risk of syncope. Too rapid an injection exceeding 1 mL/minute may lead to hypotension and cardiac syncope [see Dosage and Administration (2.1)].

5.3 Arrhythmias with Concomitant Digoxin Use

SPL UNCLASSIFIED SECTION

Arrhythmias may occur if Calcium Chloride Injection and digoxin are administered together. Hypercalcemia resulting from an overdose of Calcium Chloride Injection increases the risk of digoxin toxicity. Avoid the use of Calcium Chloride Injection in patients receiving digoxin. If concomitant therapy is necessary, closely monitor ECG and calcium levels [see Drug Interactions (7.1)].

5.4 Tissue Necrosis and Calcinosis

SPL UNCLASSIFIED SECTION

Administration of Calcium Chloride Injection in patients with local trauma may result in calcinosis cutis due to transient increase in local calcium concentration. Calcinosis cutis can occur with or without extravasation of Calcium Chloride Injection, is characterized by abnormal dermal deposits of calcium salts, and clinically manifests as papules, plaques, or nodules that may be associated with erythema, swelling, or induration. Tissue necrosis, ulceration, and secondary infection are the most serious complications.

To minimize the risk of tissue necrosis, ulceration and calcinosis, administer Calcium Chloride Injection slowly through a small needle into a large vein [see Dosage and Administration (2.1)]. Avoid extravasation or accidental injection into perivascular tissues. Should perivascular infiltration occur, immediately discontinue intravenous administration at that site and treat as needed.

5.5 Aluminum Toxicity

SPL UNCLASSIFIED SECTION

Calcium Chloride Injection contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature (preterm) neonates and preterm infants, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day can accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower amounts of aluminum.

Exposure to aluminum from Calcium Chloride Injection at the recommended dose is not more than 10 mcg [see Dosage and Administration (2.2) and Description (11)]. When prescribing Calcium Chloride Injection in patients receiving parenteral nutrition solutions, limit the total daily patient exposure to aluminum to no more than 5 mcg/kg/day.

6 ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

The following serious adverse reactions are also described elsewhere in the labeling:

The following adverse reactions have been identified in literature and postmarketing reports of calcium chloride. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure:

  • Nervous system disorders: Paraesthesia (upon rapid injection), calcium taste
  • General disorders and administration site conditions: Sense of oppression, sense of “heat wave”, local burning sensation, injection site extravasation, injection site reactions
  • Cardiovascular disorders: Peripheral vasodilatation, decreased blood pressure

7 DRUG INTERACTIONS

DRUG INTERACTIONS SECTION

     

7.1 Digoxin

SPL UNCLASSIFIED SECTION

Avoid the concomitant use of Calcium Chloride Injection with digoxin. If concomitant use is unavoidable, monitor ECG closely during administration of Calcium Chloride Injection.

Synergistic arrhythmias may occur with concomitant use. The use of Calcium Chloride Injection may result in hypercalcemia which increases the risk of digoxin toxicity [see Warnings and Precautions (5.3)].

7.2 Calcium Channel Blockers

SPL UNCLASSIFIED SECTION

Concomitant use of Calcium Chloride Injection and calcium channel blockers may reduce the response to calcium channel blockers. Avoid concomitant use. If concomitant use is unavoidable, monitor blood pressure closely during administration of Calcium Chloride Injection.

7.3 Drugs That Increase the Risk of Hypercalcemia

SPL UNCLASSIFIED SECTION

Increase frequency of monitoring of calcium concentrations in patients taking concomitant Calcium Chloride Injection and other drugs that increase the risk of hypercalcemia (e.g., calcipotriene, estrogen, lithium, parathyroid hormone, teriparatide, thiazide diuretics, Vitamin A, and Vitamin D).

8 USE IN SPECIFIC POPULATIONS

USE IN SPECIFIC POPULATIONS SECTION

     

8.1 Pregnancy

PREGNANCY SECTION

Risk Summary

Administration of Calcium Chloride Injection for the treatment of acute symptomatic hypocalcemia during pregnancy is not expected to cause major birth defects, miscarriage, or adverse maternal or fetal outcomes. There are risks to the mother and the fetus associated with development of hypocalcemia during pregnancy (see Clinical Considerations). Animal reproduction studies have not been conducted with Calcium Chloride Injection.

The estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Clinical Considerations

Disease-associated Maternal and/or Embryo/Fetal/Neonatal Risk

Maternal hypocalcemia can result in an increased rate of spontaneous abortion, premature and dysfunctional labor, and possibly preeclampsia. Infants born to mothers with hypocalcemia can develop fetal and neonatal hyperparathyroidism, which in turn can cause fetal and neonatal skeletal demineralization, subperiosteal bone resorption, osteitis fibrosa cystica and neonatal seizures.

8.2 Lactation

LACTATION SECTION

Risk Summary

Calcium is present in human milk. Administration of the approved recommended dose of Calcium Chloride Injection to the mother is not expected to cause harm to a breastfed infant. There is no information on the effects of Calcium Chloride Injection on the breastfed infant or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Calcium Chloride Injection and any potential adverse effects on the breastfed infant from Calcium Chloride Injection or from the underlying maternal condition.

8.4 Pediatric Use

PEDIATRIC USE SECTION

The safety and effectiveness of Calcium Chloride Injection for the treatment of acute symptomatic hypocalcemia have been established in pediatric patients.

The use of Calcium Chloride Injection is contraindicated in newborns if they require (or are expected to require) ceftriaxone intravenous treatment because of the risk of precipitation of ceftriaxone-calcium, regardless of whether these products would be received at different times or through separate intravenous lines [see Contraindications (4) and Warnings and Precautions (5.1)].

In pediatric patients older than 28 days of age, Calcium Chloride Injection and ceftriaxone intravenous solutions may be administered sequentially one after another if infusion lines at different sites are used, infusion lines are replaced, or infusion lines are thoroughly flushed between infusions with physiological salt solution to avoid precipitation. Do not mix or administer Calcium Chloride Injection simultaneously with ceftriaxone, even if using different infusion lines or different infusion sites as it can lead to precipitation of ceftriaxone-calcium.

Calcium Chloride Injection contains aluminum that may be associated with central nervous system and bone toxicity. Because of immature renal function, preterm infants receiving prolonged parenteral nutrition treatment with Calcium Chloride Injection may be at higher risk of aluminum toxicity [see Warnings and Precautions (5.2)] .

8.5 Geriatric Use

GERIATRIC USE SECTION

Clinical studies of Calcium Chloride Injection did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.

8.6 Renal Impairment

RENAL IMPAIRMENT SUBSECTION

The use of Calcium Chloride Injection in patients with renal impairment may increase the risk of a higher calcium-phosphorus product. For patients with renal impairment, initiate Calcium Chloride Injection at the lowest recommended dose within the recommended dose range [see Dosage and Administration (2.2)]. Monitor serum calcium levels frequently based on the severity of the renal impairment and the risk of a high calcium-phosphorus product (e.g., every 4 hours).

10 OVERDOSAGE

OVERDOSAGE SECTION

Overdosage of Calcium Chloride Injection may lead to hypercalcemia. Symptoms of hypercalcemia typically develop when the total serum calcium concentration is ≥12 mg/dL, and include shortening of QT interval, bradycardia, hypertension, anorexia, nausea, vomiting, bowel hypomotility and constipation, muscle weakness, bone pain, decreased concentration, depression, weakness, fatigue, confusion, hallucinations, disorientation, hypotonicity, seizures, and coma. Hypercalcemia effects on kidney include diminished ability to concentrate urine and diuresis.

In the event of overdosage, promptly discontinue Calcium Chloride Injection , the patient should be re-evaluated and appropriate countermeasures should be instituted, if necessary [see Warnings and Precautions (5), Adverse Reactions (6)].

11 DESCRIPTION

DESCRIPTION SECTION

10% Calcium Chloride Injection, USP is a sterile, nonpyrogenic, hypertonic solution for single administration only. Each mL contains 100 mg (1.4 mEq/mL) of calcium chloride, dihydrate (1.4 mEq each of Ca++ and Cl-) in water for injection. It is provided in a 10 mL single-dose syringe for intravenous injection. The solution contains no bacteriostat, antimicrobial agent or added buffer. The pH of 10% Calcium Chloride Injection, USP is 5.5 to 7.5 when diluted with water for injection to make a 5% solution. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. The osmolar concentration is 2.04 mOsmol/mL (calc.). 10% Calcium Chloride Injection, USP is oxygen sensitive.

Calcium Chloride, USP dihydrate is chemically designated CaCl2 • 2H2O (dihydrate) and is described as white, odorless fragments or granules freely soluble in water.

Calcium Chloride Injection, USP contains no more than 1,000 mcg/L of aluminum [see Warnings and Precautions (5.2)].

12 CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

     

12.1 Mechanism of Action

MECHANISM OF ACTION SECTION

Intravenous administration of calcium chloride increases serum ionized calcium concentration. Calcium chloride dissociates into ionized calcium in plasma.

12.2 Pharmacodynamics

PHARMACODYNAMICS SECTION

The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of Calcium Chloride Injection have not been fully characterized.

12.3 Pharmacokinetics

PHARMACOKINETICS SECTION

Absorption

Calcium Chloride Injection is 100% bioavailable following intravenous injection.

Distribution

Calcium in the body is distributed mainly in skeleton (99%) and 1% is distributed within the extracellular fluids and soft tissues. About 50% of total serum calcium is in the ionized form and represents the biologically active part; 8% to 10% serum calcium is bound to organic and inorganic acid, respectively; and approximately 40% is protein-bound (primarily to albumin).

Elimination

Metabolism

Calcium itself does not undergo direct metabolism.

Excretion

Calcium is excreted by the kidney through a combination of glomerular filtration and tubular reabsorption. A significant increase in urinary excretion of calcium was observed during and after intravenous infusion of calcium chloride.

Specific Populations

The effect of age, sex, race, ethnicity, renal or hepatic impairment on the pharmacokinetics of calcium have not been evaluated in clinical studies.

13 NONCLINICAL TOXICOLOGY

NONCLINICAL TOXICOLOGY SECTION

     

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION

Carcinogenicity, mutagenicity, and fertility have not been assessed with Calcium Chloride Injection.

16 HOW SUPPLIED/STORAGE AND HANDLING

HOW SUPPLIED SECTION

Calcium Chloride Injection, USP (clear solution) is supplied in single-dose syringes as follows:

Unit of Sale and Product Description

Strength

NDC

Bundle of 10

10 mL Ansyr® Plastic Syringe

10% (1,000 mg/10 mL)

(100 mg/mL)

0409-1631-10

The 100 mg/mL concentration represents 27 mg or 1.4 mEq of elemental calcium per mL of solution.

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). [See USP Controlled Room Temperature.]

17 PATIENT COUNSELING INFORMATION

INFORMATION FOR PATIENTS SECTION

Inform patients or caregivers of the following risks of Calcium Chloride Injection:

Arrhythmias with Concomitant Digoxin Use

Arrhythmias may occur if Calcium Chloride Injection and Digoxin are administered together [see Warnings and Precautions (5.3)].

Tissue Necrosis and Calcinosis

Administration of Calcium Chloride Injection may result in calcinosis cutis including tissue necrosis, ulceration, and secondary infection. [see Warnings and Precautions (5.4)].

Aluminum Toxicity

Calcium Chloride Injection contains aluminum that may be toxic [see Warnings and Precautions (5.5)].

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

Logo
Logo

LAB-1022-4.0

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 Label
PRINCIPAL DISPLAY PANEL - 10 mL Syringe Label

PRINCIPAL DISPLAY PANEL - 10 mL Syringe Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 ▶

PRINCIPAL DISPLAY PANEL - 10 mL Syringe Carton
PRINCIPAL DISPLAY PANEL - 10 mL Syringe Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
828527calcium chloride 10 % in 10 ML Prefilled SyringePSN21
82852710 ML calcium chloride 100 MG/ML Prefilled SyringeSCD21
828527calcium chloride 10 % in 10 ML Prefilled SyringeSY21

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-1631-10Calcium Chloride10 in 1 CONTAINERINJECTION, SOLUTION1021
0409-1631-40Calcium Chloride10 mL in 1 SYRINGE, PLASTICINJECTION, SOLUTION1021
0409-1631-40Calcium Chloride1 in 1 CARTONINJECTION, SOLUTION121

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-1631-10ML - Milliliter0409-163150b9ea6c-0f3c-4fab-9b8b-4b14df6fddf912012-07-24
0409-1631-40ML - Milliliter0409-1631ade4afc1-3b6c-45af-a768-ae60f1d77ebe12020-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CALCIUM CHLORIDEACTIVE INGREDIENTM4I0D6VV5M10
CHLORIDE IONACTIVE MOIETYQ32ZN4869810
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CB10
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I10
WATERINACTIVE INGREDIENT059QF0KO0R10

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0409-16310409-1631-40, 0409-1631-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
202025-11-26monthly-update2026-06-03 17:44:45

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 6 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRAVENOUS78 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, SOLUTION / INTRAVENOUS1037 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, SOLUTION / INTRAVENOUS1037 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRAVENOUS78 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRAVENOUS78 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, SOLUTION / INTRAVENOUS1037 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates

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
N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINERCALCIUM CHLORIDE100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N021117-001AP

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 22:38:342026-08N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-2884e616aacf4f…
2026-08-18 06:07:402026-07N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-2887673890dc5c…
2021-03-12 10:30 UTC2021-03N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-283f01610625f2…
2019-09-15 20:21 UTC2019-09N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-28b00525d2431f…
2019-07-19 19:46 UTC2019-07N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-283f0d92c62455…
2023-05-13 08:27 UTC2023-05N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-28053a50430f4f…
2023-01-26 05:58 UTC2023-01N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021117-001CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER100MG/MLINJECTABLE / INJECTIONAPRLD, RS2000-01-28f41ea6bd6efb…

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 22:38:342026-08N021117-001AP184e616aacf4f…
2026-08-18 06:07:402026-07N021117-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021117-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021117-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021117-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021117-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021117-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021117-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021117-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021117-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021117-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021117-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021117-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021117-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021117-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021117-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021117-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021117-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021117-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021117-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021117-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021117-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021117-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03N021117-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021117-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021117-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021117-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09N021117-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07N021117-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021117-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021117-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021117-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021117-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021117-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021117-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021117-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05N021117-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01N021117-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021117-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021117-001AP1f41ea6bd6efb…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Calcium ChlorideCALCIUM CHLORIDEHospira, Inc.c4c65e48-85f8-4dcf-6281-06e40959cc792026-02-02Warnings, Adverse reactionsExact identifier
ndc (package): 0409-1631-10
ndc (package): 0409-1631-40
ndc (product): 0409-1631
ndc11 (package): 00409163110
ndc11 (package): 00409163140
spl id: 49e4fe58-c11a-414a-bc10-c0020ead7d53
spl set id: c4c65e48-85f8-4dcf-6281-06e40959cc79

Reported adverse events (FAERS/openFDA)#

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