Home › NDC Lookup › Ingredients › Calcium Chloride › 75907-0223-10
💉image loading
(from DailyMed)

Calcium Chloride 100 mg/mL Injection, Solution — NDC 75907-223-10 (Billing 75907-0223-10)

by Dr. Reddy's Laboratories Inc. · 10 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE

This is a package of Calcium Chloride 100 mg/mL Injection, Solution from Dr. Reddy's Laboratories Inc., marketed since Jan 2025 and currently FDA-listed. It is this product's only package size.

NDC 75907-0223-10
🏷️ FDA NDC (as labeled) 75907-223-10 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 →

This page is curated, coded, and maintained by

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) 75907-223-10
Product NDC 75907-223
11-digit billing NDC 75907022310
RxCUI 828525
UNII M4I0D6VV5M
Application # ANDA219342
SPL Set ID 7e94daf8-b71f-49d9-af3f-3a78ae9dfc8a
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 2025-01-20
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance CALCIUM CHLORIDE
TE code (Orange Book) AP · RLD · RS
Quick answers
  • RxCUI (RxNorm): 828525
Why two NDCs? The FDA registers this code as 75907-223-10 — 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 → 75907-0223-10. 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

📗 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.
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
75907-0223-10 You're viewing this Main listing 10 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE 2025-01-20 — 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/mL 72572-0052-10 Civica, 10 vials — AP FDA listed —
Calcium Chloride 100 mg/mLthis 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

🏛️
2025
On the market since
Jan 2025
📍
2026
Currently FDA-listed
1 year 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerDr. Reddy's Laboratories Inc.
Application holderEXTROVIS AG
FDA applicationANDA219342 (ANDA)
Labeler code75907
First marketedJan 2025
Product typeHuman Prescription Drug
Portfolio160 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 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧪 Nonclinical Toxicology 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 82 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 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 ~2 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. 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 80 words ▾

3 DOSAGE FORMS AND STRENGTHS Calcium chloride injection, USP (single-dose) supplied as: 10% (1,000 mg/10 mL) (100 mg/mL) in a plastic 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% (1000 mg/10 mL) (100 mg/mL) in a Plastic vial. The 100 mg/mL concentration represents 27 mg or 1.4 mEq of elemental calcium per mL of solution. ( 3 )

⛔ Contraindications 128 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 Administra… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions 209 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 Dr. Reddy’s Laboratories at 1-888-375-3784 or 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 seve… [Excerpted — this section continues on DailyMed.]

🆘 Overdosage 104 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.

📦 How Supplied / Storage and Handling 78 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Calcium chloride injection, USP (clear solution) is supplied in single-dose plastic vials as follows: NDC No. Container Strength Vial Size Carton 75907-223-35 Plastic Vial 10% (1,000 mg/10 mL) 100 mg/mL 10 mL 10 vials 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 160 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 plastic vial 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 1.54 to 2.54 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 114 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) ].

Manufactured by: Maiva Pharma Private Limited No.32, SIPCOT Industrial Complex, Phase-I, Hosur-635126, Tamil Nadu, India (IND) Manufactured For: Dr. Reddy’s Laboratories Inc. Princeton, NJ 08540 USA.

REV 12/2024 "Image Description"

🧪 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.

📄 Package Label / Principal Display Panel 29 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 10% Calcium chloride Injection, USP - NDC 75907-223-10- Carton Label 10% Calcium chloride Injection, USP - NDC 75907-223-35 - Vial Label "Image Description" "Image Description"

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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
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 Dr. Reddy's Laboratories Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Dr. Reddy's Laboratories 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.
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.
← 75907-0207-04 · Dr. 75907-0224-04 · Dr. →
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.