NDC 80830-1673-04 — calcium gluconate 98 mg/mL Injection, Solution

🆔 Identity & classification

FDA NDC (as labeled) 80830-1673-4

Product NDC 80830-1673

11-digit billing NDC 80830167304

RxCUI 197435, 1668248, 1668250

UNII CZN0MI5R31

UPC 0380830167242, 0380830167419

Application # ANDA216611

SPL Set ID 13d7cfc9-ff7a-437e-8c21-d9709ac07d48

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 2026-04-13

Route INTRAVENOUS

Dosage form INJECTION, SOLUTION

Substance CALCIUM GLUCONATE MONOHYDRATE

GPI-14 79100030002010

GCN Seq No 001356

GCN 03820

HICL code 000585

Ingredient (HICL) Calcium Gluconate

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 GLUC 5,000 MG/50 ML VL

FDB brand name Calcium Gluconate

Legend status F — Federal legend — prescription drug or device

TE code (Orange Book) AP · RLD · RS

Why two NDCs? The FDA registers this code as 80830-1673-4 — a 5-4-1 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 package segment → 80830-1673-04. 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, Other dermatologicals

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.

🏭 Manufacturer & labeler

LabelerAmneal Pharmaceuticals Private Limited

Application holderAMNEAL EU LTD

FDA applicationANDA216611 (ANDA)

Labeler code80830

First marketedApr 2026

Product typeHuman Prescription Drug

Portfolio27 products on file

🔎 All NDCs from Amneal Pharmaceuticals Private Limited

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.

🩺 Clinical

Label name CALCIUM GLUC 5,000 MG/50 ML VL Ingredient Calcium Gluconate

📗 Our plain-language guide HelloPharmacist

Calcium gluconate injection is used to treat a sudden, serious drop in blood calcium levels — called acute symptomatic hypocalcemia. When your calcium gets too low, it can cause mu...
What is calcium gluconate actually used for?
It's given through an IV line — either as a slow, controlled injection (bolus) or as a continuous drip over a longer period. The method depends on how severe your symptoms are and...
How is it given — is it a shot or a drip?

📖 Read our full Calcium Gluconate guide →

Patient education

📘 MedlinePlus patient leaflet ↗

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.

🧪 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.

💲 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 system	Per mL	Per 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.

Try another pack size: 10 vials 25 vials

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.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
calcium gluconate 98 mg/mL 00143-9184-25	Hikma	25 vials	—	AP	FDA listed	—
Calcium Gluconate 98 mg/mL 51662-1347-01	HF	50 ml	—	AP	FDA listed	—
Calcium Gluconate 100 mg/mL 63323-0360-19	Fresenius	25 vials	—	AP	FDA listed	—
Calcium Gluconate 100 mg/mL 65145-0171-25	Caplin	25 vials	—	AP	FDA listed	—
Calcium Gluconate 100 mg/mL 68462-0790-25	GLENMARK	25 vials	—	AP	FDA listed	—
Calcium Gluconate 98 mg/mL 70069-0727-25	Somerset	25 vials	—	AP	FDA listed	—
calcium gluconate 98 mg/mLthis 80830-1673-04	Amneal	10 vials	—	AP	FDA listed	—
calcium gluconate 98 mg/mL 00143-9180-25	Hikma	25 vials	—	AP	FDA listed	—
Calcium Gluconate 98 mg/mL 00264-5600-52	B.	100 ml	—	AP	FDA listed	—
Calcium Gluconate 98 mg/mL 71872-7222-01	Medical	1 vial	—	AP	FDA listed	—
calcium gluconate 98 mg/mL 80830-1674-02	Amneal	10 vials	—	AP	FDA listed	—
Calcium Gluconate 98 mg/mL 84549-0360-19	ProPharma	10 ml	—	AP	FDA listed	—
Calcium Gluconate 98 mg/mL 51662-1312-01	HF	10 ml	—	AP	FDA listed	—
Calcium Gluconate 98 mg/mL 70069-0728-20	Somerset	20 vials	—	AP	FDA listed	—
calcium gluconate 98 mg/mL 80830-1672-02	Amneal	10 vials	—	AP	FDA listed	—
Calcium Gluconate 98 mg/mL 70518-4178-00	REMEDYREPACK	25 vials	—	AP	FDA listed	—
Calcium Gluconate 98 mg/mL 00404-9831-10	Henry	1 vial	—	AP	FDA listed	—
calcium gluconate 98 mg/mL 70518-4355-00	REMEDYREPACK	25 vials	—	AP	FDA listed	—
Calcium Gluconate 98 mg/mL 65219-0630-19	Fresenius	25 vials	—	AP	FDA listed	—
calcium gluconate 98 mg/mL 00143-9185-20	Hikma	20 vials	—	AP	FDA listed	—
Calcium Gluconate 98 mg/mL 00404-9764-10	Henry	1 vial	—	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

🏛️

2026

On the market since

Apr 2026

📍

2026

Currently FDA-listed

listed with the FDA

🔓

·

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.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.

10 vials80830-1673-02 53 Rx · $12,562

25 vials80830-1673-05 No Medicaid data

10 vials this page80830-1673-04 No Medicaid data

Drug total (last 4 qtrs): 53 Rx · 1,961 units · $12,562 gross reimbursed

Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Calcium Gluconate — the program that covers self-administered drugs. 4 manufacturers.

⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Calcium Gluconate. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.

Period

Total Part D spend

$11.5K

Claims incl. refills

180

Beneficiaries

42

Spend / beneficiary

$274.10

Spend / claim

$63.96

Trend by period

💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Calcium Gluconate — the ingredient across all brands.

Top reported reactions

Pain1,717

Fatigue1,698

Rheumatoid Arthritis1,410

Nausea1,387

Alopecia1,345

Vomiting1,292

Pemphigus1,273

Age at onset

Neonate65

Infant26

Child45

Adolescent26

Adult945

Elderly516

Reporter sex

Male · 30%

Female · 70%

Unknown · 0%

Serious outcomes

Death2,532

Reports over time (by year) — tap or hover for the count & year

Most recent year is provisional (FAERS lags ~3 months).

Where does this data come from?

Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
80830-1673-02	10 VIAL in 1 CARTON (80830-1673-2) / 50 mL in 1 VIAL (80830-1673-1)	2024-05-13	Active
80830-1673-05	25 VIAL in 1 CARTON (80830-1673-5) / 50 mL in 1 VIAL (80830-1673-1)	2024-05-13	Active
80830-1673-04 You're viewing this	10 VIAL in 1 CARTON (80830-1673-4) / 50 mL in 1 VIAL	2026-04-13	Active

Pack size FAQ

What quantity is in NDC 80830-1673-04?

NDC 80830-1673-04 is listed by the FDA — 10 vial in 1 carton / 50 ml in 1 vial.

What NDC number is used to bill for this package of calcium gluconate 98 mg/mL Injection, Solution?

Bill NDC 80830-1673-04 — the 11-digit billing format is 80830167304. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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)	— 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 FDA registers it as 80830-1673-4, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 80830-1673-04, written without dashes as 80830167304. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 80830-1673-04, the first segment (80830) is the labeler code FDA assigned to Amneal Pharmaceuticals Private Limited; the middle segment (1673) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) identifies this exact package size and type. Together they name one specific package of one specific product.

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 Amneal Pharmaceuticals Private Limited. Listing status can change — the directory data on this page refreshes weekly.

Does this product come in other package sizes?

Yes — the FDA directory lists 2 other package presentations of this same product, including 10 vials (80830-1673-02), 25 vials (80830-1673-05). Each has its own NDC and its own page — see the package list near the top of this page.

Who lists this product with the FDA?

Amneal Pharmaceuticals Private Limited 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.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. 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

🎯 Indications and Usage 82 words ▾

1 INDICATIONS AND USAGE Calcium gluconate injection is indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia. Limitations of Use The safety of calcium gluconate injection for long term use has not been established. Calcium gluconate injection is a form of calcium indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia.

( 1 ) Limitations of Use: The safety of calcium gluconate injection for long term use has not been established. ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Contains 100 mg of calcium gluconate per mL which contains 9.3 mg (0.465 mEq) of elemental calcium. ( 2.1 ) Administer intravenously (bolus or continuous infusion) via a secure intravenous line. ( 2.1 ) See Full Prescribing Information (FPI) for dilution instructions, administration rates and appropriate monitoring.

( 2.1 ) Individualize the dose within the recommended range in adults and pediatric patients depending on the severity of symptoms of hypocalcemia, the serum calcium level and the acuity of onset of hypocalcemia. See Table 1 in the FPI for dosing recommendations in mg of calcium gluconate for neonates, pediatric and adult patients. ( 2.2 ) Measure serum calcium during intermittent infusions every 4 to 6 hours and during continuous infusion every 1 to 4 hours.

( 2.3 ) Calcium gluconate injection is not physically compatible with fluids containing phosphate or bicarbonate. Precipitation may result if mixed. See FPI for all drug incompatibilities.

( 2.5 ) Supplied in a single-dose vial or pharmacy bulk package (PBP). For PBP, dispense single-doses to many patients in a pharmacy admixture program; use within 4 hours of puncture. ( 2.6 )

2.1Important Administration Instructions Calcium gluconate injection contains 100 mg of calcium gluconate per mL which contains 9.3 mg (i.e. 0.465 mEq) of elemental calcium. Dilute calcium gluconate injection prior to use in 5% dextrose or normal saline and assess for potential drug or intravenous fluid incompatibilities [see Dosage and Administration (2.5) ].

Inspect calcium gluconate injection visually prior to administration. The solution should appear clear and colorless to slightly yellow. Do not administer if there is particulate matter or discoloration.

Use the diluted solution immediately after preparation. Administer calcium gluconate injection intravenously via a secure intravenous line to avoid calcinosis cutis and tissue necrosis [see Warnings and Precautions (5.3) ] . Administer calcium gluconate injection by bolus administration or continuous infusion.

For bolus intravenous administration Dilute the dose [see Dosage and Administration (2.2) ] of calcium gluconate injection in 5% dextrose or normal saline to a concentration of 10 mg/mL to 50 mg/mL prior to administration. Administer the dose slowly and DO NOT exceed an infusion rate of 200 mg/minute in adults or 100 mg/minute in pediatric patients, including neonates. Monitor patients, vitals and electrocardiograph (ECG) during administration [see Warnings and Precautions (5.4) ] .

For continuous intravenous infusion Dilute calcium gluconate injection in 5% dextrose or normal saline to a concentration of 5.8 mg/mL to 10 mg/mL prior to administration. Administer at the rate recommended in Table 1 [see Dosage and Administration (2.2) ] and monitor patients, vitals, calcium and ECG during the infusion [see Warnings and Precautions (5.4) ] . Calcium gluconate injection is supplied in single-dose vials and pharmacy bulk packages [see Dosage and Administration (2.6) ].

2.2Recommended Dosage Individualize the dose of calcium gluconate injection within the recommended range depending on the severity of symptoms of hypocalcemia, the serum calcium level and the acuity of onset of hypocalcemia. Table 1 provides dosing recommendations for calcium gluconate injection in mg of calcium gluconate for neonates, pediatric and adult patients. Table 1: Dosing Recommendations in mg of Calcium Gluconate for Neonate, Pediatric and Adult Patients Patient Population Initial Dose Subsequent Doses (if needed) Bolus Continuous Infusion Neonate (≤ 1 month) 100 mg/kg to 200 mg/kg 100 mg/kg to 200 mg/kg every 6 hours Initiate at 17 to 33 mg/kg/hour Pediatric (> 1 month to < 17 years) 29 mg/kg to 60 mg/kg 29 mg/kg to 60 mg/kg every 6 hours Initiate at 8 to 13 mg/kg/hour Adult 1,000 mg to 2,000 mg 1,000 mg to 2,000 mg every 6 hours Initiate at 5.4 to 21.5 mg/kg/hour For bolus administration, DO NOT exceed an infusion rate of:…

💊 Dosage Forms and Strengths 109 words ▾

3 DOSAGE FORMS AND STRENGTHS Calcium Gluconate Injection, USP is a sterile, clear, colorless to slightly yellow solution available in the following: Single-dose vial: 1,000 mg per 10 mL (100 mg per mL) Single-dose vial: 5,000 mg per 50 mL (100 mg per mL) Pharmacy bulk package: 10,000 mg per 100 mL (100 mg per mL) Each mL of calcium gluconate injection, USP contains 9.3 mg (0.465 mEq) of elemental calcium. Injection: ( 3 ) Single-dose vial: 1,000 mg per 10 mL (100 mg per mL) Single-dose vial: 5,000 mg per 50 mL (100 mg per mL) Pharmacy bulk package: 10,000 mg per 100 mL (100 mg per mL)

⛔ Contraindications 40 words ▾

4 CONTRAINDICATIONS Calcium gluconate injection is contraindicated in: Hypercalcemia. Neonates (28 days of age or younger) receiving ceftriaxone [see Warnings and Precautions (5.2) ]. Hypercalcemia. ( 4 ) Neonates (28 days of age or younger) receiving ceftriaxone. ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Arrhythmias with Concomitant Cardiac Glycoside Use: If concomitant therapy is necessary, calcium gluconate injection should be given slowly in small amounts and close ECG monitoring is recommended. (5.1) End-Organ Damage due to Intravascular Ceftriaxone-Calcium Precipitates: Concurrent use of intravenous ceftriaxone may cause life-threatening precipitates. Cases of fatal outcomes in neonates have occurred.

(4, 5.2) Tissue Necrosis and Calcinosis: Calcinosis cutis can occur with or without extravasation of calcium gluconate injection. Tissue necrosis, ulceration and secondary infection are the most serious complications. If extravasation occurs or clinical manifestations of calcinosis cutis are noted, immediately discontinue intravenous administration at that site and treat as needed.

(5.3) Hypotension, Bradycardia and Cardiac Arrhythmias with Rapid Administration: To avoid adverse reactions that may follow rapid intravenous administration, calcium gluconate injection should be diluted with 5% dextrose or normal saline and infused slowly, with careful ECG monitoring for cardiac arrhythmias. (5.4) Aluminum Toxicity: This product contains aluminum, up to 400 mcg per liter, that may be toxic. (5.5)

5.1Arrhythmias with Concomitant Cardiac Glycoside Use Cardiac arrhythmias may occur if calcium and cardiac glycosides are administered together. Hypercalcemia increases the risk of digoxin toxicity. Administration of calcium gluconate injection should be avoided in patients receiving cardiac glycosides.

If concomitant therapy is necessary, calcium gluconate injection should be given slowly in small amounts and with close ECG monitoring [see Drug Interactions (7.1) ] .

5.2End-Organ Damage due to Intravascular Ceftriaxone-Calcium Precipitates Concomitant use of ceftriaxone and calcium gluconate injection is contraindicated in neonates (28 days of age or younger) due to cases of fatal outcomes in neonates in which a crystalline material was observed in the lungs and kidneys at autopsy after ceftriaxone and calcium were administrated simultaneously through the same intravenous line. Concomitant administration can lead to the formation of ceftriaxone-calcium precipitates that may act as emboli, resulting in vascular spasm or infarction [see Contraindications (4) ].

In patients older than 28 days of age, ceftriaxone and calcium gluconate injection may be administered sequentially, provided the infusion lines are thoroughly flushed between infusions with a compatible fluid. Do not administer ceftriaxone simultaneously with calcium gluconate injection via a Y-site in any age group.

5.3Tissue Necrosis and Calcinosis Intravenous administration of calcium gluconate injection and 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 gluconate 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.

If extravasation occurs or clinical manifestations of calcinosis cutis are noted, immediately discontinue intravenous administration at that site and treat as needed.

5.4Hypotension, Bradycardia and Cardiac Arrhythmias with Rapid Administration Rapid injection of calcium gluconate injection may cause vasodilation, decreased blood pressure, bradycardia, cardiac arrhythmias, syncope and cardiac arrest. To avoid adverse reactions that may follow rapid intravenous administration, calcium gluconate injection should be diluted with 5% dextrose or normal saline and infused slowly. If rapid intravenous bolus of calcium gluconate injection is required, the rate of intravenous administration should not exceed 200 mg/minute in adults and 100 mg/minute in pediatric patients and ECG monitoring during admi…

🤒 Adverse Reactions 204 words ▾

6 ADVERSE REACTIONS The following serious adverse reactions are also described elsewhere in the labeling: Arrhythmias with Concomitant Cardiac Glycoside Use [see Warnings and Precautions (5.1) ] End-Organ Damage due to Intravascular Ceftriaxone-Calcium Precipitates [see Warnings and Precautions (5.2) ] Tissue Necrosis and Calcinosis [see Warnings and Precautions (5.3) ] Hypotension, Bradycardia and Cardiac Arrhythmias [see Warnings and Precautions (5.4) ] Aluminum toxicity [see Warnings and Precautions (5.5) ] The following adverse reactions associated with the use of calcium gluconate were identified in the literature.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure. Cardiovascular : Vasodilation, decreased blood pressure, bradycardia, cardiac arrhythmia, syncope, cardiac arrest. Administration site reactions : Local soft tissue inflammation, local necrosis, calcinosis cutis and calcification due to extravasation.

The most common adverse events with calcium gluconate injection are local soft tissue inflammation and necrosis, calcinosis cutis and calcification that are related to extravasation. Other adverse events include vasodilation, decreased blood pressure, bradycardia, cardiac arrhythmia, syncope and cardiac arrest. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions 173 words ▾

7 DRUG INTERACTIONS Cardiac Glycoside : Synergistic arrhythmias may occur if calcium and cardiac glycosides are administered together. ( 7.1 ) Calcium Channel Blockers : Administration of calcium may reduce the response. ( 7.2 ) Drugs that may cause hypercalcemia: Vitamin D, vitamin A, thiazide diuretics, estrogen, calcipotriene and teriparatide administration may cause hypercalcemia.

Monitor plasma calcium concentrations in patients taking these drugs concurrently. ( 7.3 )

7.1Cardiac Glycosides Hypercalcemia increases the risk of digoxin toxicity, while digoxin may be therapeutically ineffective in the presence of hypocalcemia. Synergistic arrhythmias may occur if calcium and cardiac glycosides are administered together. Avoid administration of calcium gluconate injection in patients receiving cardiac glycosides; if considered necessary, administer calcium gluconate injection slowly in small amounts and monitor ECG closely during administration.

7.2Calcium Channel Blockers Administration of calcium may reduce the response to calcium channel blockers.

7.3Drugs that may cause Hypercalcemia Vitamin D, vitamin A, thiazide diuretics, estrogen, calcipotriene and teriparatide administration may cause hypercalcemia. Monitor plasma calcium concentrations in patients taking these drugs concurrently.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Geriatric use : Dosing in elderly patients should be cautious, usually starting at the low end of the dosage range. ( 8.5 ) Renal impairment: Initiate with the lower limit of the dosage range and monitor serum calcium levels every 4 hours. ( 8.6 , 2.4 )

8.1Pregnancy Risk summary Limited available data with calcium gluconate injection use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. There are risks to the mother and the fetus associated with hypocalcemia in pregnancy [see Clinical Considerations] . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

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

Infants born to mothers with hypocalcemia should be carefully monitored for signs of hypocalcemia or hypercalcemia, including neuromuscular irritability, apnea, cyanosis and cardiac rhythm disorders.

8.2Lactation Risk summary Calcium is present in human milk as a natural component of human milk. It is not known whether intravenous administration of calcium gluconate injection can alter calcium concentration in human milk. There are no data on the effects of calcium gluconate 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 gluconate injection and any potential adverse effects on the breastfed child from calcium gluconate injection or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness of calcium gluconate injection have been established in pediatric patients for the treatment of acute, symptomatic hypocalcemia. Pediatric approval for calcium gluconate injection, including doses, is not based on adequate and well-controlled clinical studies. Safety and dosing recommendations in pediatric patients are based on published literature and clinical experience [see Dosage and Administration (2.2) ] .

Concomitant use of ceftriaxone and calcium gluconate injection is contraindicated in neonates (28 days of age or younger) due to reports of fatal outcomes associated with the presence of lung and kidney ceftriaxone-calcium precipitates. In patients older than 28 days of age, ceftriaxone and calcium gluconate injection may be administered sequentially, provided the infusion lines are thoroughly flushed between infusions with a compatible fluid [ see Contraindications (4) and Warnings and Precautions (5.2) ] . This product contains up to 400 mcg/L aluminum which may be toxic, particularly for premature neonates due to immature renal function.

Parenteral administration of aluminum greater than 4 to 5 mcg/kg/day is associated with central nervous system and bone toxicity [see Warnings and Precautions (5.5) ] .

8.5Geriatric Use In general dose selection for an elderly patient should start at the lowest dose of the recommended dose range, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant disease or other drug therapy.

8.6Renal Impairment For patients with renal impairment, initiate calcium gluconate injection at the lowest dose of the recommended dose ranges across all age groups. Monitor serum calcium levels every 4 hours [see Dosage and Administration (2.4) ].

8.7 Hepatic Impairment Hepat…

🆘 Overdosage 87 words ▾

10 OVERDOSAGE Overdosage of calcium gluconate injection may result in hypercalcemia. Symptoms of hypercalcemia typically develop when the total serum calcium concentration is ≥ 12 mg/dL. Neurologic symptoms include depression, weakness, fatigue and confusion at lower levels, with patients experiencing hallucinations, disorientation, hypotonicity, seizures and coma.

Effects on the kidney include diminished ability to concentrate urine and diuresis. If overdose of calcium gluconate injection occurs immediately discontinue administration and provide supportive treatments to restore intravascular volume as well as promote calcium excretion in the urine if necessary.

🧬 Clinical Pharmacology 179 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Intravenous administration of calcium gluconate increases serum ionized calcium level. Calcium gluconate dissociates into ionized calcium in plasma. Ionized calcium and gluconate are normal constituents of body fluids.

12.3Pharmacokinetics Absorption Calcium gluconate injection is 100% bioavailable following intravenous injection. Metabolism Calcium itself does not undergo direct metabolism. The release of ionized calcium from intravenous administration of calcium gluconate is direct and does not seem to be affected by the first pass through the liver.

Distribution Calcium in the body is distributed mainly in skeleton (99%). Only 1% of the total body calcium 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 and approximately 40% is protein-bound (primarily to albumin). Elimination Studies have shown a relationship between urinary calcium excretion and the intravenous administration of calcium gluconate, with a significant increase in urinary calcium excretion observed after the intravenous administration of calcium gluconate.

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Calcium Gluconate Injection USP, 100 mg per mL is supplied as a sterile, clear, colorless to slightly yellow solution filled in plastic vial. It is available as follows: 1,000 mg per 10 mL (100 mg per mL): 10 mL Single-dose Vial: NDC 80830-1672-1 25 Vials in a Carton: NDC 80830-1672-5 10 Vials in a Carton: NDC 80830-1672-2 5,000 mg per 50 mL (100 mg per mL): 50 mL Single-dose Vial: NDC 80830-1673-1 25 Vials in a Carton: NDC 80830-1673-5 10 Vials in a Carton: NDC 80830-1673-2 10,000 mg per 100 mL (100 mg per mL): 100 mL Pharmacy Bulk Package Vial: NDC 80830-1674-8 25 Vials in a Carton: NDC 80830-1674-5 10 Vials in a Carton: NDC 80830-1674-2 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Do not freeze. Preservative Free. Discard any unused portion in the single-dose vial immediately or the Pharmacy Bulk Package vial within 4 hours after initial closure puncture.

Each dose dispensed from the Pharmacy Bulk Package vial must be used immediately. The diluted solution must be used immediately. NOTE: Supersaturated solutions are prone to precipitation.

The precipitate, if present, may be dissolved by warming the vial to 60° to 80°C, with occasional agitation, until the solution becomes clear. Shake vigorously. Allow to cool to room temperature before dispensing.

Use injection only if clear immediately prior to use.

📋 Description 207 words ▾

11 DESCRIPTION Calcium gluconate injection USP, 100 mg per mL is a sterile, clear, colorless to slightly yellow, preservative-free, nonpyrogenic, supersaturated solution of calcium gluconate, a form of calcium, for intravenous use. The chemical name of calcium gluconate monohydrate, USP is calcium D-gluconate (1:2) monohydrate. The structural formula is: Molecular formula: C 12 H 22 CaO 14 •H 2 O Molecular weight: 448.39 g/mol Solubility in water: 3.5 g/100 mL at 25°C Calcium gluconate monohydrate, USP is a white, crystalline granules or powder.

It is soluble in boiling water, sparingly soluble in water and insoluble in alcohol. Calcium Gluconate Injection, USP is available as 1,000 mg per 10 mL (100 mg per mL) or 5,000 mg per 50 mL (100 mg per mL) in a single-dose vial or 10,000 mg per 100 mL (100 mg per mL) in a pharmacy bulk package. Each mL of calcium gluconate injection, USP contains: 100 mg of calcium gluconate (equivalent to 94 mg of calcium gluconate and 4.5 mg of calcium saccharate tetrahydrate), hydrochloric acid and/or sodium hydroxide for pH adjustment (6.0 to 8.2) and sterile water for injection, q.s.

It contains no antimicrobial agent. Each mL of calcium gluconate injection, USP contains 9.3 mg (0.465 mEq) of elemental calcium. 1

💬 Information for Patients 49 words ▾

17 PATIENT COUNSELING INFORMATION Advise the patient that the risks associated with infusion including local tissue inflammation, local necrosis and calcinosis [see Warnings and Precautions (5.3) ] . Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Parenteral Unit Ahmedabad 382110, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 12-2023-01

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

synergistic: When two things taken together produce a larger effect than adding their separate effects would predict.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

agitation: A state of feeling restless and upset and being unable to relax, sometimes with pacing or fidgeting.

apnea: A pause or temporary stop in breathing.

arrhythmia: A heartbeat that is too fast, too slow, or irregular instead of steady.

bolus: A single dose given all at once, often as a quick push into a vein.

bradycardia: A slower-than-normal heart rate, usually under 60 beats per minute.

cardiac arrest: A sudden stop of the heart's pumping that cuts off blood flow to the body, which is a medical emergency.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

cyanosis: A bluish color of the skin, lips, or nails caused by too little oxygen in the blood.

depression: A lasting low mood with loss of interest that affects everyday life.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

erythema: Redness of the skin caused by increased blood flow, often from irritation or inflammation.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

Excretion: How the body removes a medicine or its leftover pieces, mainly through the urine or stool.

extravasation: The accidental leaking of an injected medicine out of the vein into the surrounding tissue, which can cause pain, swelling, or tissue damage.

Full Prescribing Information: The complete, detailed label for a prescription medicine that follows the summary highlights.

hepatic impairment: Reduced liver function, meaning the liver does not work as well as normal at processing substances, including medicines.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hypercalcemia: A higher-than-normal level of calcium, a mineral, in the blood.

hypocalcemia: A lower-than-normal level of calcium, a mineral, in the blood.

hypotension: Blood pressure that is lower than normal, which can cause dizziness or fainting.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

infusion: Slowly delivering fluid or medicine into a vein over a period of time, usually through a drip.

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

irritability: Getting annoyed, frustrated, or angry more easily than usual.

lactation: The making and release of milk from a mother's breasts after giving birth.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

neonatal: Relating to a newborn baby during its first four weeks of life.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

parenteral: Given by injection or drip into the body rather than swallowed by mouth.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

Prescribing Information: The official, detailed document approved by the FDA that tells health professionals how to use a prescription medicine.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

single-dose vial: A small container holding one dose of medicine, meant to be used once and then thrown away.

spontaneous abortion: The natural loss of a pregnancy in its early stages, also called a miscarriage.

syncope: The medical term for fainting, a brief loss of consciousness from a temporary drop in blood flow to the brain.

ulceration: The forming of an open sore on the skin or on a lining inside the body, such as the stomach.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

vasodilation: Widening of blood vessels, which lets more blood flow through and can lower blood pressure.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

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

🔗 Related NDC lookups

🧪 All Calcium Gluconate NDCsSame ingredient 🏭 All Amneal labeler NDCsLabeler code 80830 📚 All Blood Coagulation Factor NDCsDrug class 📖 Read the Calcium Gluconate drug informationUses, warnings & side effects

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Where does this data come from?

Other drugs sharing this product’s First Databank therapeutic class (HIC3). Each links to that NDC’s page in our directory.