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Calcium Chloride 100 mg/mL Injection, Solution — NDC 72572-0052-10 package photo
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Calcium Chloride 100 mg/mL Injection, Solution — NDC 72572-052-10 (Billing 72572-0052-10)

by Civica, Inc. · 10 VIAL, GLASS in 1 BOX / 10 mL in 1 VIAL, GLASS

This is a package of Calcium Chloride 100 mg/mL Injection, Solution from Civica, Inc., marketed since Apr 2021 and currently FDA-listed. It is this product's only package size.

NDC 72572-0052-10
🏷️ FDA NDC (as labeled) 72572-052-10 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 72572-052-10
Product NDC 72572-052
11-digit billing NDC 72572005210
NCPDP billing unit ML — per mL (volume)
RxCUI 828525
UNII M4I0D6VV5M
Application # ANDA209088
SPL Set ID 7fa5d8e8-0610-4892-907e-5ef630a56e76
Established class (EPC) Blood Coagulation Factor; Cations; Phosphate Binder
Mechanism of action Phosphate Chelating Activity
Physiologic effect Increased Coagulation Factor Activity
Chemical class Calcium; Divalent
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-04-02
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance CALCIUM CHLORIDE
TE code (Orange Book) AP · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 79100010002010
GPI class Calcium Chloride
GCN Seq No 001350
GCN 03760
HICL code 000582
Ingredient (HICL) Calcium Chloride
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C1
Therapeutic class — intermediate (HIC2) Drugs Affecting Electrolyte Balance
HIC3 code C1F
Therapeutic class — specific (HIC3) Calcium Replacement
AHFS code 40:12.00.00
AHFS class Replacement Preparations
FDB label name CALCIUM CHLORIDE 10% VIAL
FDB brand name Calcium Chloride
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 001350
  • GCN: 03760
  • GPI-14 (Medi-Span): 79100010002010
  • HICL (First Databank): 000582
  • AHFS class code: 40:12.00.00
  • RxCUI (RxNorm): 828525
Why two NDCs? The FDA registers this code as 72572-052-10 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 72572-0052-10. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Calcium class.

Drug family (ATC) Calcium, Electrolyte solutions, Acidifiers
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name CALCIUM CHLORIDE 10% VIAL Ingredient Calcium Chloride
📖 What it is MedlinePlus · NLM

Calcium injection is used in children and adults to treat low levels of calcium in the body. Calcium is in a class of medications called minerals. It works by increasing the supply of calcium necessary for many of the body's functions.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • When your calcium level drops to a dangerous level very quickly, your body needs calcium delivered directly into the bloodstream right away — there's no time to wait for a pill to...
  • Why am I getting calcium chloride through an IV instead of just taking a calcium pill?
  • Many people feel a warm or flushing sensation, a tingling (especially if it goes in a little fast), or notice a chalky or metallic taste. Some feel mild pressure or a burning sensa...
  • This is a really important thing for your care team to know. Calcium chloride and digoxin together can cause dangerous heart rhythm problems, so your team will generally try to avo...
📖 Read our full Calcium Chloride guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J0618 No ASP payment limit on file for J0618 this quarter.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Billing & reimbursement

FDA NDC (as labeled)72572-052-10
11-digit billing NDC72572-0052-10
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ0618
DescriptorINJECTION, CALCIUM CHLORIDE, 2 MG
Billing units / pkg50 units
How the units are derivedThis package is 10 ML; the HCPCS unit is 2 MG, so one package = 50 billing units.
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
72572-0052-10 You're viewing this Main listing 10 VIAL, GLASS in 1 BOX / 10 mL in 1 VIAL, GLASS 2021-04-02 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Calcium Chloride 100 mg/mL 00404-9830-10 Henry 1 syringe — AP FDA listed —
Calcium Chloride 100 mg/mL 00517-6710-10 American 10 vials — AP FDA listed —
Calcium Chloride Dihydrate 100 mg/mL 70069-0773-10 Somerset 10 vials — AP FDA listed —
calcium chloride 100 mg/mL 70121-2309-07 Amneal 10 vials — AP FDA listed —
Calcium Chloride 100 mg/mLthis 72572-0052-10 Civica, 10 vials — AP FDA listed —
Calcium Chloride 100 mg/mL 75907-0223-10 Dr. 10 vials — AP FDA listed —
calcium chloride 100 mg/mL 76483-0108-02 SQUARE 10 vials — AP FDA listed —
Calcium Chloride 100 mg/mL 71872-7045-01 Medical 1 syringe — AP FDA listed —
Calcium Chloride 100 mg/mL 00409-1631-10 Hospira, 1 syringe — AP FDA listed —
calcium chloride 100 mg/mL 70121-2308-04 Amneal 1 syringe — AP FDA listed —
Calcium Chloride 100 mg/mL 51662-1452-01 HF 1 syringe — AP FDA listed —
calcium chloride 100 mg/mL 00121-1099-02 PAI 10 vials — AP FDA listed —
calcium chloride 100 mg/mL 72658-1879-02 Eskayef 10 vials — AP FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2021
On the market since
Apr 2021
📍
2026
Currently FDA-listed
5 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

3 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerCivica, Inc.
Application holderAMERICAN REGENT INC
FDA applicationANDA209088 (ANDA)
Labeler code72572
First marketedApr 2021
Product typeHuman Prescription Drug
Portfolio95 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 83 words ▾

1 INDICATIONS AND USAGE 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. Calcium Chloride Injection is a form of calcium indicated for the treatment of adult and pediatric and patients with acute symptomatic hypocalcemia.

( 1 ) Limitations of Use : The safety and effectiveness of Calcium Chloride Injection for long-term use has not been established

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Administer Calcium Chloride Injection by slow intravenous infusion (not to exceed 1 mL/minute), in a central or deep vein. ( 2.1 ) Do not use intramuscularly or subcutaneously. ( 2.1 ) Do not administer unless solution is clear and seal is intact.

( 2.1 ) Stop the administration if the patient complains of any administration- related discomfort, it may be resumed when symptoms disappear. ( 2. 1) The recommended adult dose is from 200 mg to 1,000 mg.

( 2. 2) The recommended pediatric dose is from 2.7 to 5 mg/kg of calcium chloride. ( 2.2 ) Repeated injections may be required because of rapid calcium excretion.

( 2.2 ) See the full prescribing information for the recommended starting dose in patients with renal impairment. ( 2.3 ) 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. ( 2.4 )

2.1Important Administration Instructions 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.

2.2Recommended Dosage and Administration The recommended dose range of Calcium Chloride Injection in: Adults is from 200 mg to 1,000 mg. Pediatric patients is from 2.7 to 5 mg/kg of calcium chloride. Dosing of this Calcium Chloride Injection product is not possible in patients who require doses less than 200 mg because the recommended dose cannot be achieved with the supplied vial.

For patients who require doses less than 200 mg, use another calcium chloride injection product that allows dosing of less than 200 mg. Individualize the dose for a patient within these dose ranges depending on serum ionized calcium level, severity of hypocalcemia symptoms, and the acuity of hypocalcemia onset. Repeated injections may be required because of rapid excretion of calcium.

2.3Recommended Starting Dose in Patients with Renal Impairment The recommended starting dose of Calcium Chloride Injection in [see Use in Specific Populations ( 8.6) ] : Adults with renal impairment is 200 mg. Pediatric patients is 2.7 mg/kg of calcium chloride.

2.4Drug Incompatibilities 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.

💊 Dosage Forms and Strengths 81 words ▾

3 DOSAGE FORMS AND STRENGTHS Calcium Chloride Injection, USP (single-dose) supplied as: 10% 1 gram/10 mL (100 mg/mL) in a glass vial. The 100 mg/mL concentration represents 27 mg or 1.4 mEq of elemental calcium per mL of solution. Calcium Chloride Injection, USP (single-dose) is supplied as: ( 3 ) 10% (1 gram /10 mL) (100 mg/mL) in a glass vial. The 100 mg/mL concentration represents 27 mg or 1.4 mEq of elemental calcium per mL of solution. ( 3 )

⛔ Contraindications 130 words ▾

4 CONTRAINDICATIONS 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 )] . Calcium Chloride Injection is contraindicated in: Patients with ventricular fibrillation.

( 4 ) Patients with asystole and electromechanical dissociation. ( 4 ) Newborns (up to 28 days of age) if they require (or are expected to require) ceftriaxone intravenous treatment, regardless of whether these products would be received at different times or through separate intravenous lines ( 4 , 5.1 )] .

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS End-Organ Damage due to Intravascular Ceftriaxone-Calcium Precipitates: Calcium Chloride Injection is contraindicated in newborns (up to 28 days of age) if they require (or are expected to require) ceftriaxone intravenous treatment. In patients older than 28 days of age, do not mix or administer simultaneously with ceftriaxone intravenous solutions, even via different infusion lines or at different infusion sites as it can lead to precipitation of ceftriaxone-calcium. ( 5.1 ) Hypotension, Bradycardia, Arrhythmias, and Syncope with Rapid Administration: Too rapid an injection exceeding 1 mL/minute may lead to hypotension and syncope.

( 2.1 , 5.2 ) Arrhythmias with Concomitant Digoxin Use: Avoid use of Calcium Chloride Injection in patients receiving digoxin. Closely monitor ECG and calcium levels if concomitant therapy is necessary. ( 5.3 , 7.1 ) Tissue Necrosis and Calcinosis: Administer Calcium Chloride Injection slowly through a small needle into a large vein to minimize the risk of tissue necrosis, ulceration and calcinosis.

Avoid extravasation or accidental injection into perivascular tissues. Immediately discontinue administration should perivascular infiltration occur. ( 2.1 , 5.4 ) Aluminum Toxicity: Risk of toxicity with prolonged administration if kidney function is impaired.

Premature neonates are particularly at risk. 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. ( 5.5 )

5.1End-Organ Damage due to Intravascular Ceftriaxone-Calcium Precipitates 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 )] .

5.2Hypotension, Bradycardia, Arrhythmias, and Syncope with Rapid Administration 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 )].

5.3Arrhythmias with Concomitant Digoxin Use 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 )] .

5.4Tissue Necrosis and Calcinosis Administ… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions 219 words ▾

6 ADVERSE REACTIONS The following serious adverse reactions are also described elsewhere in the labeling: • End-Organ Damage due to Intravascular Ceftriaxone-Calcium Precipitates [see Warnings and Precautions ( 5.1 )] • Hypotension, Bradycardia, Arrhythmias, and Syncope with Rapid Administration [see Warnings and Precautions ( 5.2 )] • Arrhythmias with Concomitant Digoxin Use [see Warnings and Precautions ( 5.3 )] • Tissue Necrosis and Calcinosis [see Warnings and Precautions ( 5.4 )] • Aluminum toxicity [see Warnings and Precautions ( 5.5 )] 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 Adverse reactions have included paraesthesia (upon rapid injection), calcium taste, sense of oppression, sense of “heat wave”, local burning sensation, injection site extravasation, injection site reactions, peripheral vasodilatation, and decreased blood pressure.

(6) To report SUSPECTED ADVERSE REACTIONS, contact American Regent, Inc. at 1-800-734-9236or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS Digoxin: Avoid concomitant use with Calcium Chloride Injection. If concomitant use is unavoidable, monitor ECG closely during administration of Calcium Chloride Injection. ( 5.3 , 7.1 ) Calcium Channel Blockers: Avoid concomitant use with Calcium Chloride Injection.

If concomitant use is unavoidable, monitor blood pressure closely during administration of Calcium Chloride Injection. ( 7.2 ) Drugs That Increase the Risk of Hypercalcemia: Increase the frequency of calcium concentration monitoring in patients taking Calcium Chloride Injection concomitantly with other drugs that increase the risk of hypercalcemia. ( 7.3 )

7.1Digoxin 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 )] .

7.2Calcium Channel Blockers 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.

7.3Drugs That Increase the Risk of Hypercalcemia 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).

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy 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.

8.2Lactation 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.

8.4Pediatric Use 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 )].

8.5Geriatric Use 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.

8.6Renal Impairment 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 se… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy 177 words ▾

8.1Pregnancy 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.

🧒 Pediatric Use 205 words ▾

8.4Pediatric Use 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 )].

🧓 Geriatric Use 32 words ▾

8.5Geriatric Use 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.

🆘 Overdosage 105 words ▾

10 OVERDOSAGE 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 )] .

🧬 Clinical Pharmacology 190 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Intravenous administration of calcium chloride increases serum ionized calcium concentration. Calcium chloride dissociates into ionized calcium in plasma.

12.2Pharmacodynamics The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of Calcium Chloride Injection have not been fully characterized.

12.3Pharmacokinetics 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.

🧬 Mechanism of Action 22 words ▾

12.1Mechanism of Action Intravenous administration of calcium chloride increases serum ionized calcium concentration. Calcium chloride dissociates into ionized calcium in plasma.

📦 How Supplied / Storage and Handling 80 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Calcium Chloride Injection, USP (clear solution) is supplied in single-dose vials as follows: Unit of Sale and Product Description Strength NDC Each carton contains 10 single-dose vials. 10% (1,000 mg/10 mL) (100 mg/mL) 72572- 052 -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.]

📋 Description 159 words ▾

11 DESCRIPTION 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 vial for intravenous injection.

The solution contains no bacteriostat, antimicrobial agent or added buffer. The pH of 10% Calcium Chloride Injection, USP is 6.3 (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 CaCl 2 • 2H 2 O (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 )].

💬 Information for Patients 107 words ▾

17 PATIENT COUNSELING INFORMATION 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 )].

Mfd for: Civica, Inc. Lehi, Utah 84043 Mfd by: American Regent, Inc. New Albany, OH 43054 RQ1098-B Revised 03/2024 civicacompanylogo

🧬 Pharmacokinetics 140 words ▾

12.3Pharmacokinetics 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.

🧬 Pharmacodynamics 25 words ▾

12.2Pharmacodynamics The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of Calcium Chloride Injection have not been fully characterized.

🧪 Nonclinical Toxicology 21 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity, mutagenicity, and fertility have not been assessed with Calcium Chloride Injection.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 18 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity, mutagenicity, and fertility have not been assessed with Calcium Chloride Injection.

📄 Package Label / Principal Display Panel 87 words ▾

PRINCIPAL DISPLAY PANEL - Container Label NDC 72572- 052 -10 Rx Only 10% Calcium Chloride Injection, USP 1 Gram/10 mL (100 mg/mL) For Intravenous Use Only Sterile, nonpyrogenic. 10 mL Single-dose Vial vial label

PRINCIPAL DISPLAY PANEL - Carton Labeling NDC 72572-052-10 Rx Only 10% Calcium Chloride Injection, USP 1 Gram/10 mL (100 mg/mL) Represents 27 mg (1.4 mEq) Ca**/mL For Intravenous Use Only 10 x 10 mL Single-dose Vials Mfd for: Civica, Inc., Lehi, UT 84043 Mfd by: American Regent, Inc. New Albany, OH 43054 carton10ml

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Civica, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Civica, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J0618 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 72572-0050-10 · Civica, 72572-0054-25 · Civica, →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.