HomeNDC LookupIngredientsCalcium Chloride Injection › 64253-0900-36
Calcium Chloride 100 mg/mL Injection, Solution — NDC 64253-0900-36 package photo

Calcium Chloride 100 mg/mL Injection, Solution

by Medefil, Inc. · 60 SYRINGE, PLASTIC in 1 BOX (64253-900-36) / 10 mL in 1 SYRINGE, PLASTIC (64253-900-30)
NDC 64253-0900-36
🏷️ FDA NDC (as labeled) 64253-900-36 billing pads the product segment with a zero
This package
Contains10 mL in 1 syringe, plastic Pack sizes2 compare ↓
Also comes in: 10 syringes 64253-0900-91
Rx only Generic On market Non-controlled ⚠ On shortage
🗂️ 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 →
⚠️
Active FDA shortage. Some presentations of Calcium Chloride Injection are currently reported in shortage by the FDA. This exact package may or may not be affected — see the shortage details. Shortage details →

🆔 Identity & classification

FDA NDC (as labeled) 64253-900-36
Product NDC 64253-900
11-digit billing NDC 64253090036
NCPDP billing unit ML — per mL (volume)
RxCUI 828527
UNII M4I0D6VV5M
Application # ANDA211553
SPL Set ID 90b8936e-61f2-5318-e053-2995a90aac44
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 2019-08-22
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance CALCIUM CHLORIDE
GPI-14 79100010002010
GPI class Calcium Chloride
GCN Seq No 001349
GCN 03751
HICL code 000582
Ingredient (HICL) Calcium Chloride
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C1
Therapeutic class — intermediate (HIC2) Drugs Affecting Electrolyte Balance
HIC3 code C1F
Therapeutic class — specific (HIC3) Calcium Replacement
AHFS code 40:12.00.00
AHFS class Replacement Preparations
FDB label name CALCIUM CHLORIDE 1 GM/10ML SYR
FDB brand name Calcium Chloride
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 64253-900-36 — 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 → 64253-0900-36. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Calcium class.

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

🏭 Manufacturer & labeler

LabelerMedefil, Inc.
Application holderMEDEFIL INC
FDA applicationANDA211553 (ANDA)
Labeler code64253
First marketedAug 2019
Product typeHuman Prescription Drug
Portfolio4 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 CHLORIDE 1 GM/10ML SYR Ingredient Calcium Chloride
📗 Our plain-language guide HelloPharmacist
  • When your calcium level drops to a dangerous level very quickly, your body needs calcium delivered directly into the bloodstream right away — there's no time to wait for a pill to...
  • Why am I getting calcium chloride through an IV instead of just taking a calcium pill?
  • Many people feel a warm or flushing sensation, a tingling (especially if it goes in a little fast), or notice a chalky or metallic taste. Some feel mild pressure or a burning sensa...
  • This is a really important thing for your care team to know. Calcium chloride and digoxin together can cause dangerous heart rhythm problems, so your team will generally try to avo...
📖 Read our full Calcium Chloride guide →
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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

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

💲 Pricing

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

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 10 syringes
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Calcium Chloride 100 mg/mL 00409-1631-10 Hospira, 1 syringe AP FDA listed
Calcium Chloride 100 mg/mL 51662-1209-01 HF 1 syringe FDA listed
Calcium Chloride 100 mg/mL 51662-1379-01 HF 1 syringe AP FDA listed
Calcium Chloride 100 mg/mL 51662-1452-01 HF 1 syringe AP FDA listed
Calcium Chloride 100 mg/mLthis 64253-0900-36 Medefil, 60 syringes AP FDA listed
calcium chloride 100 mg/mL 70121-2308-04 Amneal 1 syringe AP FDA listed
Calcium Chloride 100 mg/mL 70518-4180-00 REMEDYREPACK 10 syringes AP FDA listed
Calcium Chloride 100 mg/mL 71872-7044-01 Medical 1 syringe FDA listed
Calcium Chloride 100 mg/mL 71872-7045-01 Medical 1 syringe AP FDA listed
Calcium Chloride 100 mg/mL 71872-7193-01 Medical 1 syringe AP FDA listed
Calcium Chloride 100 mg/mL 76329-3304-01 International 10 syringes AP FDA listed
Calcium Chloride 100 mg/mL 84549-0304-01 ProPharma 10 ml AP FDA listed
Calcium Chloride 100 mg/mL 70518-4734-00 REMEDYREPACK 10 syringes 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

🏛️
2019
On the market since
Aug 2019
📍
2026
Currently FDA-listed
7 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.

🔬 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 Chloride Injection — the ingredient across all brands.

Top reported reactions

Pain427
Injury407
Nausea339
Anxiety291
Renal Failure273
Pyrexia268
Hypotension244

Age at onset

Neonate10
Infant9
Child2
Adolescent21
Adult178
Elderly147

Reporter sex

3,022 reports
Male · 41%
Female · 59%
Unknown · 0%

Serious outcomes

Hospitalization1,371
Death702
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 315 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
64253-0900-36 You're viewing this 60 SYRINGE, PLASTIC in 1 BOX (64253-900-36) / 10 mL in 1 SYRINGE, PLASTIC (64253-900-30) 2019-08-22 Active
64253-0900-91 10 SYRINGE, PLASTIC in 1 BOX (64253-900-91) / 10 mL in 1 SYRINGE, PLASTIC 2020-09-21 Active

Pack size FAQ

What quantity is in NDC 64253-0900-36?
NDC 64253-0900-36 is listed by the FDA — 60 syringe, plastic in 1 box / 10 ml in 1 syringe, plastic.
What NDC number is used to bill for this package of Calcium Chloride 100 mg/mL Injection, Solution?
Bill NDC 64253-0900-36 — the 11-digit billing format is 64253090036. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 64253-900-36, 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: 64253-0900-36, written without dashes as 64253090036. 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 64253-0900-36, the first segment (64253) is the labeler code FDA assigned to Medefil, Inc.; the middle segment (0900) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (36) 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 Medefil, Inc.. 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 10 syringes (64253-0900-91). 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?
Medefil, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 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 46 words

10% Calcium Chloride Injection, USP is indicated for the treatment of hypocalcemia in those conditions requiring a prompt increase in plasma calcium levels. 10% Calcium Chloride Injection, USP is indicated for the treatment of hypocalcemia in those conditions requiring a prompt increase in plasma calcium levels.

⏱️ Dosage and Administration ~1 min read

10% Calcium Chloride Injection, USP is administered only by slow intravenous injection (not to exceed 1 mL/min), preferably in a central or deep vein. The usual precautions for intravenous therapy should be observed. If time permits, the solution should be warmed to body temperature.

The injection should be halted if the patient complains of any discomfort; it may be resumed when symptoms disappear. Following injection, the patient should remain recumbent for a short time. The usual adult dosage in hypocalcemic disorders ranges from 200 mg to 1 g (2 to 10 mL) at intervals of 1 to 3 days depending on the response of the patient and/or results of serum ionized calcium determinations.

Repeated injections may be required because of rapid excretion of calcium. The pediatric dosage in hypocalcemic disorders ranges from 2.7 to 5.0 mg/kg hydrated calcium chloride (or 0.136 to 0.252 mEq elemental calcium per kg, or 0.027 to 0.05 mL of 10% Calcium Chloride Injection per kg). No data from clinical trials is available about repeated dosages, though textbook references recommend repeat dosages q 4 to 6 hours.

Caution: 10% Calcium Chloride Injection consists of 1 gram of calcium chloride in a 10 mL syringe, or 100 mg/mL. This concentration represents 27 mg or 1.4 mEq of elemental calcium per mL. Thus, one 10 mL syringe provides 270 mg of elemental calcium.

The dosage recommendation in various references is given either as amount of calcium chloride or amount of elemental calcium, and often it is not specified. Ionized calcium concentrations should be measured, to assist in dosage adjustment. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

See PRECAUTIONS. To prevent needle-stick injuries, needles should not be recapped, purposely bent or broken by hand.

Contraindications 36 words

Calcium chloride is contraindicated for cardiac resuscitation in the presence of ventricular fibrillation or in patients with the risk of existing digitalis toxicity. Calcium chloride is not recommended in the treatment of asystole and electromechanical dissociation.

⚠️ Warnings 130 words

10% Calcium Chloride Injection, USP is irritating to veins and must not be injected into tissues, since severe necrosis and sloughing may occur. Great care should be taken to avoid extravasation or accidental injection into perivascular tissues. WARNING: This product contains aluminum that may be toxic.

Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity.

Tissue loading may occur at even lower rates of administration.

🤒 Adverse Reactions 117 words

Rapid injection may cause the patient to complain of tingling sensations, a calcium taste, a sense of oppression or "heat wave". Injections of calcium chloride are accompanied by peripheral vasodilatation as well as a local "burning" sensation and there may be a moderate fall in blood pressure. Should perivascular infiltration occur, I.V. administration at that site should be discontinued at once.

Local infiltration of the affected area with 1% procaine hydrochloride, to which hyaluronidase may be added, will often reduce venospasm and dilute the calcium remaining in the tissues locally. Local application of heat may also be helpful. To report SUSPECTED ADVERSE REACTIONS, contact Medefil, Inc., at 1-630-682-4600 or www.medefilinc.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

🤰 Pregnancy 46 words

Animal reproduction studies have not been conducted with calcium chloride. It also is not known whether calcium chloride can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Calcium chloride should be given to a pregnant woman only if clearly needed.

🧒 Pediatric Use 13 words

Safety and effectiveness are based on similar clinical conditions in children and adults.

🧓 Geriatric Use 58 words

An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

🆘 Overdosage 54 words

Too rapid injection may produce lowering of blood pressure and cardiac syncope. Persistent hypercalcemia from overdosage of calcium is unlikely because of rapid excretion. In the event of untoward effects from excessive calcium administration, the drug should be discontinued promptly, the patient re-evaluated and appropriate countermeasures instituted, if necessary. See PRECAUTIONS and ADVERSE REACTIONS.

🧬 Clinical Pharmacology 123 words

Calcium is the fifth most abundant element in the body and the major fraction is in the bony structure. Calcium plays important physiological roles, many of which are poorly understood. It is essential for the functional integrity of the nervous and muscular systems.

It is necessary for normal cardiac function and is one of the factors that operate in the mechanisms involved in the coagulation of blood. Calcium chloride in water dissociates to provide calcium (Ca++) and chloride (Cl−) ions. They are normal constituents of the body fluids and are dependent on various physiological mechanisms for maintenance of balance between intake and output.

Approximately 80% of body calcium is excreted in the feces as insoluble salts; urinary excretion accounts for the remaining 20%.

📦 How Supplied / Storage and Handling 112 words

10% Cacliumn Chloride Injection, USP is supplied omn single-dose containers as follows: Unit of Sale Container Total Strength / Total Volume (Concentration) Each Needle NDC 64253-900-91 10 mL Single-dose prefilled syringes, individually pouched, in a carton of 10s Plastic Syringe 1000 mg/10 mL (100 mg/mL) NDC 64253-900-30 10 mL fill in 12 mL Syringe Single-dose prefilled syringes, individually pouched None NDC 64253-900-36 10 mL Single-dose prefilled syringes, individually pouched, in a carton of 60s Plastic Syringe 1000 mg/10 mL (100 mg/mL) NDC 64253-900-30 10 mL fill in 12 mL Syringe Single-dose prefilled syringes, individually pouched None Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.].

Do not freeze.

📋 Description 208 words

10% Calcium Chloride Injection, USP is a sterile, nonpyrogenic, hypertonic solution. Each mL contains 100 mg (1.4 mEq/mL) of calcium chloride, dihydrate (1.4 mEq each of Ca++ and Cl−) in water for injection. It is provided in a 10 mL Unit of Use Syringe to facilitate prompt intravenous injection.

The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended for use only as a single-dose injection. The pH of 10% Calcium Chloride Injection, USP is 5.5 to 7.5 when diluted with water for injection to make a 5% solution. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment.

The osmolar concentration is 2.04 mOsmol/mL (calc.). 10% Calcium Chloride Injection, USP is oxygen sensitive. Calcium Chloride, USP dihydrate is chemically designated CaCl2 • 2H2O (dihydrate) and is described as white, odorless fragments or granules freely soluble in water.

The plastic syringe is molded from a specially formulated polypropylene. Water permeates from inside the container at an extremely slow rate which will have an insignificant effect on solution concentration over the expected shelf life. Solutions in contact with the plastic container may leach our certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the syringe material.

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