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Calcium Gluconate 20 mg/mL Injection, Solution — NDC 65219-0164-50 package photo

Calcium Gluconate 20 mg/mL Injection, Solution

by Fresenius Kabi USA, LLC · 24 BAG in 1 CASE (65219-164-50) / 100 mL in 1 BAG (65219-164-01)
NDC 65219-0164-50
🏷️ FDA NDC (as labeled) 65219-164-50 billing pads the product segment with a zero
Rx only Brand On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

🆔 Identity & classification

FDA NDC (as labeled) 65219-164-50
Product NDC 65219-164
11-digit billing NDC 65219016450
NCPDP billing unit ML — per mL (volume)
RxCUI 2117608, 2117610
UNII CZN0MI5R31
Application # NDA208418
SPL Set ID 7f5101e0-abf9-4fcf-8986-c799e3333434
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 NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-06-17
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance CALCIUM GLUCONATE MONOHYDRATE
GPI-14 79109902192007
GPI class Calcium Gluconate-NaCl
GCN Seq No 079278
GCN 45748
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 GLU 2,000MG/100ML-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 65219-164-50 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 65219-0164-50. 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

LabelerFresenius Kabi USA, LLC
Application holderFRESENIUS KABI USA LLC
FDA applicationNDA208418 (NDA)
Labeler code65219
First marketedJun 2021
Product typeHuman Prescription Drug
Portfolio554 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name CALCIUM GLU 2,000MG/100ML-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 →

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.

4 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 systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · 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)65219-164-50
11-digit billing NDC65219-0164-50
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ0612
DescriptorInjection, calcium gluconate (fresenius kabi), per 10 mg
Billing units / pkg4,800 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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Calcium Gluconate in Sodium Chloride 20 mg/mL 44567-0621-24 WG 24 pouches — — FDA listed —
Calcium Gluconate 20 mg/mLthis 65219-0164-50 Fresenius 100 ml — AP FDA listed —
Calcium Gluconate 20 mg/mL 80830-2363-09 Amneal 24 pouches — AP FDA listed —
Calcium Gluconate in Sodium Chloride 20 mg/mL 44567-0620-24 WG 24 pouches — — FDA listed —
Calcium Gluconate 20 mg/mL 80830-2362-09 Amneal 24 pouches — AP FDA listed —
Calcium Gluconate 20 mg/mL 65219-0162-10 Fresenius 50 ml — AP FDA listed —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
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

🏛️
2017
First FDA approval
Jun 2017
📍
2026
Currently FDA-listed
9 years listed
🛡️
2037
Latest patent/protection listed
not a guaranteed launch date
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Jul 2037. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Jun 15, 2017 AP TE-rated RLD RS ⏳ ~10.9 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 10130646 — drug product
US 10130646 — drug product
2017 2019 2021 2023 2025 2027 2029 2031 2033 2035 2037
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (2)
PatentTypeUse codeExpires
US 10130646 ↗ Drug product — Jul 25, 2037
US 10130646 ↗ Drug product — Jul 25, 2037
Common questions
Is there a generic version of CALCIUM GLU 2,000MG/100ML-NACL?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for CALCIUM GLU 2,000MG/100ML-NACL. See the alternatives section for substitutable, lower-cost products.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
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.

📊 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

0 reports
Male · 30%
Female · 70%
Unknown · 0%

Serious outcomes

Death2,532
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,057 0
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 NDCDescription Marketing startStatus
65219-0164-50 You're viewing this 24 BAG in 1 CASE (65219-164-50) / 100 mL in 1 BAG (65219-164-01) 2021-06-17 Active

🧭 About this NDC listing & data coverage

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

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 65219-164-50, 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: 65219-0164-50, written without dashes as 65219016450. 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 65219-0164-50, the first segment (65219) is the labeler code FDA assigned to Fresenius Kabi USA, LLC; the middle segment (0164) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (50) 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 Fresenius Kabi USA, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Fresenius Kabi USA, LLC 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 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 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. 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 ) Limitations of Use The safety of Calcium Gluconate Injection for long term use has not been established.

⏱️ 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 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 )

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 port cap provides visual tamper evidence.

Do not use if 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, break off BLUE Infusion Port Cap with the arrow pointing away from the solution container.

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 BLUE infusion port, twist and push spike until fully inserted. The BLUE infusion port contains a self-sealing septum that helps prevent leakage after removing the spike.

The infusion port is not intended to be spiked more than once. Suspend solution container from hanger hole. For Single Use 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…

💊 Dosage Forms and Strengths 97 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: ( 3 ) 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 44 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 S…

🤒 Adverse Reactions 211 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 Fresenius Kabi USA, LLC at 1-800-551-7176 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 2-4% and 15-20%, 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 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 dose ranges…

🤰 Pregnancy 169 words ▾

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 2-4% and 15-20%, 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.

🧒 Pediatric Use 199 words ▾

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 to 5 mcg/kg/day is associated with central nervous system and bone toxicity [see Warnings and Precautions ( 5.5 )] .

🧓 Geriatric Use 41 words ▾

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.

🆘 Overdosage 92 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 126 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Calcium Gluconate in Sodium Chloride Injection is a clear, colorless solution supplied as follows: Product Code Unit of Sale Strength Unit of Use 271621 NDC 65219-162-10 Unit of 24 1,000 mg per 50 mL (20 mg/mL) NDC 65219-162-01 50 mL fill volume in a 100 mL free flex ® bag 271645 NDC 65219-164-50 Unit of 24 2,000 mg per 100 mL (20 mg per mL) NDC 65219-164-01 100 mL free flex ® bag 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 156 words ▾

11 DESCRIPTION Calcium Gluconate in Sodium Chloride Injection is a sterile, preservative-free, nonpyrogenic, solution of calcium gluconate, a form of calcium, for intravenous use. Calcium Gluconate 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 Solubility in water: 3.5 g/100 mL at 25°C 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) in single-dose 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), hydrochloric acid and/or sodium hydroxide for pH adjustment (6.0 to 8.2) and sodium chloride 6.75 mg/mL as tonicity adjustor. Each mL of Calcium Gluconate in Sodium Chloride Injection contains 1.86 mg (0.093 mEq) of elemental calcium. Structural Formula

💬 Information for Patients 50 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 for: Lake Zurich, IL 60047 Made in Norway www.fresenius-kabi.com/us 451705A Fresenius Kabi Logo

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 65219-0162-10 · Fresenius 65219-0184-20 · Fresenius →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.