NDC 80830-2362-09 — CALCIUM GLUCONATE 20 mg/mL Injection, Solution

🆔 Identity & classification

FDA NDC (as labeled) 80830-2362-9

Product NDC 80830-2362

11-digit billing NDC 80830236209

NCPDP billing unit ML — per mL (volume)

RxCUI 2117608, 2117610

UNII CZN0MI5R31

UPC 0380830236290

Application # ANDA217174

SPL Set ID 8ee79b4c-21d3-4742-ae37-e2f562917706

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 2023-09-08

Route INTRAVENOUS

Dosage form INJECTION, SOLUTION

Substance CALCIUM GLUCONATE MONOHYDRATE

GPI-14 79109902192005

GCN Seq No 079277

GCN 45747

HICL code 045482

Ingredient (HICL) Calcium Gluc In Nacl, Iso-Osm

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 1,000MG/50ML-NACL

FDB brand name Calcium Gluconate-Nacl

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 80830-2362-9 — 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 → 80830-2362-09. 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 applicationANDA217174 (ANDA)

Labeler code80830

First marketedSep 2023

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 1,000MG/50ML-NACL Ingredient Calcium Gluc In Nacl, Iso-Osm

📖 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

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.

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

UNII 6AP9J91K4V
A calcium compound derived from sugar, used as a binder and filler in tablets and capsules to help hold ingredients together and add bulk to the medicine.
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 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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.

5 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.

💲 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	$0.1906	$228.72 / 1200 ml
Medicare drug plans payPart D · quarterly	No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J0612	$0.027 / J0612 unit	—

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)80830-2362-9

11-digit billing NDC80830-2362-09

Format5-4-1 as registered → padded to 5-4-2 for billing (zero added to the package segment)

HCPCS J-codeJ0612

DescriptorInjection, calcium gluconate (fresenius kabi), per 10 mg

Billing units / pkg2,400 units

Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk

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.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Calcium Gluconate in Sodium Chloride 20 mg/mL 44567-0620-24	WG	24 pouches	—	—	FDA listed	—
Calcium Gluconate 20 mg/mL 65219-0162-10	Fresenius	50 ml	—	AP	FDA listed	—
Calcium Gluconate 20 mg/mLthis 80830-2362-09	Amneal	24 pouches	—	AP	FDA listed	—
Calcium Gluconate in Sodium Chloride 20 mg/mL 44567-0621-24	WG	24 pouches	—	—	FDA listed	—
Calcium Gluconate 20 mg/mL 80830-2363-09	Amneal	24 pouches	—	AP	FDA listed	—
Calcium Gluconate 20 mg/mL 65219-0164-50	Fresenius	100 ml	—	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

🏛️

2023

On the market since

Sep 2023

📍

2026

Currently FDA-listed

3 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 80830-2362-09, not the drug overall. Other pack sizes report separately.

💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.

📅 Q1 2025 – Q4 2025 · 4 quarters of data

ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.

Prescriptions last 4 qtrs

14

Units reimbursed last 4 qtrs

1.1K

Gross reimbursed last 4 qtrs

$200.13

Avg / prescription

$14.30

Avg / unit

$0.1906

Latest quarter Q4 2025

0Rx

Fee-for-service vs managed care ⓘ

100% MCO

Fee-for-service · 0 Rx Managed care · 14 Rx

State Medicaid map

Units reimbursed · per 100k residents

2.72.7

gray = no data reported ⓘ

Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.

Tap or hover a state

…for its Medicaid breakdown

🏆 Top states by units · per 100k residents

1 California 2.7 /100k

National units — by quarter

💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 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.

24 pouches this page80830-2362-09 14 Rx · $200

12 pouches80830-2362-02 No Medicaid data

Drug total (last 4 qtrs): 14 Rx · 1,050 units · $200 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
80830-2362-09 You're viewing this	24 POUCH in 1 CARTON (80830-2362-9) / 1 BAG in 1 POUCH (80830-2362-1) / 50 mL in 1 BAG	2023-09-08	Active
80830-2362-02	12 POUCH in 1 CARTON (80830-2362-2) / 1 BAG in 1 POUCH / 50 mL in 1 BAG	2023-11-08	Active

Pack size FAQ

What quantity is in NDC 80830-2362-09?

NDC 80830-2362-09 is listed by the FDA — 24 pouch in 1 carton / 1 bag in 1 pouch / 50 ml in 1 bag.

What NDC number is used to bill for this package of CALCIUM GLUCONATE 20 mg/mL Injection, Solution?

Bill NDC 80830-2362-09 — the 11-digit billing format is 80830236209. 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)	✓ 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)	✓ Available

“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 80830-2362-9, 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: 80830-2362-09, written without dashes as 80830236209. 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 80830-2362-09, the first segment (80830) is the labeler code FDA assigned to Amneal Pharmaceuticals Private Limited; the middle segment (2362) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (09) 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 1 other package presentation of this same product, including 12 pouches (80830-2362-02). 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.

Does this product have a billing J-code?

Yes — this NDC cross-references HCPCS code J0612 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.

📄 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 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients

🎯 Indications and Usage 88 words ▾

1 INDICATIONS AND USAGE Calcium gluconate in sodium chloride 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 in sodium chloride 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 20 mg of calcium gluconate per mL which contains 1.86 mg (0.093 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 administration rates and appropriate monitoring.

( 2.1 ) Do not dilute calcium gluconate in sodium chloride injection prior to use. Any unused portion should be discarded. ( 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 2 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 hours to 6 hours and during continuous infusion every 1 hour 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 )

2.1Important Administration Instructions Calcium gluconate in sodium chloride injection contains 20 mg of calcium gluconate per mL which contains 1.86 mg (i.e. 0.093 mEq) of elemental calcium. See Table 1 for amounts of elemental calcium in calcium gluconate in sodium chloride injection.

Table 1: Amount of Calcium Gluconate and Elemental Calcium Total Strength per Total Volume Strength per mL Total Amount of Elemental Calcium (mg) per Total Volume Total Amount of Elemental Calcium (mEq) per Total Volume 1,000 mg per 50 mL 20 mg/mL 93 mg per 50 mL 4.65 mEq per 50 mL 2,000 mg per 100 mL 20 mg/mL 186 mg per 100 mL 9.3 mEq per 100 mL Do not dilute calcium gluconate in sodium chloride injection prior to use. Any unused portion should be discarded [see Dosage and Administration (2.5) ]. Inspect calcium gluconate in sodium chloride injection visually prior to administration.

The solution should appear clear and colorless. Do not administer if there is particulate matter or discoloration. Administer calcium gluconate in sodium chloride injection intravenously via a secure intravenous line to avoid calcinosis cutis and tissue necrosis [see Warnings and Precautions (5.3) ] .

Administer calcium gluconate in sodium chloride injection by continuous infusion at the rate recommended in Table 2 [see Dosage and Administration (2.2) ] and monitor patients, vitals, calcium and ECG during the infusion [see Warnings and Precautions (5.4) ] . Check solution container composition, lot number and expiry date. Do not admix with other drugs.

Do not use solution containers in series connections. The intact twist-off port cap provides visual tamper evidence. Do not use if twist-off port cap is prematurely removed.

Maintain strict aseptic technique during handling. INSTRUCTIONS FOR USE Always inspect the solution container before and after removal from the overwrap. Place the solution container on a clean, flat surface.

Remove the solution container from the overwrap. Check the solution container for leaks by squeezing firmly. If leaks are found, discard.

Do not use if the solution is cloudy or a precipitate is present. To Prepare for Administration Immediately before inserting the infusion set, remove twist-off port from the bag. Use a non-vented infusion set or close the air-inlet on a vented set.

Close the roller clamp of the infusion set. Hold the base of the infusion port and push spike until fully inserted. The infusion port is not intended to be spiked more than once.

Suspend solution container from hanger hole. For single-dose only. Discard unused portion.

2.2Recommended Dosage Individualize the dose of calcium gluconate in sodium chloride 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 2 provides dosing recommendations for calcium gl…

💊 Dosage Forms and Strengths 94 words ▾

3 DOSAGE FORMS AND STRENGTHS Calcium Gluconate in Sodium Chloride Injection is a clear, colorless solution available in the following: Injection: Calcium gluconate 1,000 mg per 50 mL (20 mg per mL) single-dose container. Calcium gluconate 2,000 mg per 100 mL (20 mg per mL) single-dose container. Each mL of calcium gluconate in sodium chloride injection contains 20 mg of calcium gluconate which contains 1.86 mg (0.093 mEq) of elemental calcium.

Injection: Single-dose container: 1,000 mg per 50 mL (20 mg per mL) Single-dose container: 2,000 mg per 100 mL (20 mg per mL)

⛔ Contraindications 43 words ▾

4 CONTRAINDICATIONS Calcium gluconate in sodium chloride 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 ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Arrhythmias with Concomitant Cardiac Glycoside Use: If concomitant therapy is necessary, calcium gluconate in sodium chloride 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. Do not administer ceftriaxone simultaneously with calcium gluconate in sodium chloride via a Y-site in any age group.

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 in sodium chloride 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 in sodium chloride injection should be infused slowly, with careful ECG monitoring for cardiac arrhythmias. ( 5.4 ) Aluminum Toxicity: This product contains aluminum, up to 100 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 in sodium chloride injection should be avoided in patients receiving cardiac glycosides.

If concomitant therapy is necessary, calcium gluconate in sodium chloride 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 in sodium chloride 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 in sodium chloride 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 in sodium chloride injection via a Y-site in any age group.

5.3Tissue Necrosis and Calcinosis Intravenous administration of calcium gluconate in sodium chloride 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 in sodium chloride injection, is characterized by abnormal dermal deposits of calcium salts and clinically manifests as papules, plaques, or nodules that may be associated with erythema, swelling, or induration. Tissue necrosis, ulceration and secondary infection are the most serious complications.

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 in sodium chloride 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 in sodium…

🤒 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 179 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 in sodium chloride injection in patients receiving cardiac glycosides; if considered necessary, administer calcium gluconate in sodium chloride 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 in sodium chloride 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 in sodium chloride injection and any potential adverse effects on the breastfed child from calcium gluconate in sodium chloride injection or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness of calcium gluconate in sodium chloride injection have been established in pediatric patients for the treatment of acute, symptomatic hypocalcemia. Pediatric approval for calcium gluconate in sodium chloride 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 in sodium chloride 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 100 mcg/L aluminum which may be toxic, particularly for premature neonates due to immature renal function. Parenteral administration of aluminum greater than 4 mcg/kg/day 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 in sodium chloride injection at the lowest dose of the recommended…

🆘 Overdosage 93 words ▾

10 OVERDOSAGE Overdosage of calcium gluconate in sodium chloride 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 in sodium chloride 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.

🧬 Mechanism of Action 32 words ▾

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.

📦 How Supplied / Storage and Handling 128 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Calcium Gluconate in Sodium Chloride Injection is a clear, colorless solution supplied as follows: Strength Each Unit of Sale 1,000 mg per 50 mL (20 mg per mL) NDC 80830-2362-1 1 Single-dose Intravenous Bag in an Overwrap NDC 80830-2362-9 Unit of 24 NDC 80830-2362-2 Unit of 12 2,000 mg per 100 mL (20 mg per mL) NDC 80830-2363-1 1 Single-dose Intravenous Bag in an Overwrap NDC 80830-2363-9 Unit of 24 NDC 80830-2363-2 Unit of 12 The container closure is not made with natural rubber latex.

Non-PVC, Non-DEHP, Sterile. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Product should be used within 60 days of removal from overwrap.

Preservative Free. Discard any unused portion in the single-dose container immediately.

📋 Description 194 words ▾

11 DESCRIPTION Calcium gluconate in sodium chloride injection is a sterile, clear, colorless, preservative-free, nonpyrogenic, 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 in Sodium Chloride Injection is available as 1,000 mg per 50 mL (18.8 mg per mL) or 2,000 mg per 100 mL (18.8 mg per mL) filled in single-dose infusion bags. Each mL of calcium gluconate in sodium chloride injection contains 20 mg of calcium gluconate (equivalent to 18.8 mg of calcium gluconate and 0.9 mg of calcium saccharate tetrahydrate), 6.75 mg sodium chloride as tonicity adjustor, hydrochloric acid and/or sodium hydroxide for pH adjustment (6.0 to 8.2) and water for injection.

Each mL of calcium gluconate in sodium chloride injection contains 1.86 mg (0.093 mEq) of elemental calcium. 1

💬 Information for Patients 54 words ▾

17 PATIENT COUNSELING INFORMATION Advise the patient of the risks associated with infusion of calcium gluconate in sodium chloride injection including local tissue inflammation, local necrosis and calcinosis [see Warnings and Precautions (5.3) ] . Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad 382110, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 04-2024-02

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.

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.

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.

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?

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