Prescription medicine
Calcium gluconate
Calcium gluconate is a prescription medicine with an FDA approval on record since 2017. FDA's NDC Directory lists it from 8 generic labelers.
- Generic listed
Check it at the source: the calcium gluconate FDA label on DailyMed (effective May 6, 2024, Fresenius Kabi USA, LLC); the NDA 208418 record on Drugs@FDA; every calcium gluconate label on DailyMed.
Highlights of the record
FDA label of May 6, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageCalcium Gluconate in Sodium Chloride Injection is indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia.
Forms and strengths
- 10 mg/ml
- 20 mg/ml
- 98 mg/ml
- 100 mg/ml
Injection (solution).
On the market
- Earliest approval on file
- June 15, 2017 Calcium Gluconate, Fresenius Kabi Usa; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 9 first October 14, 2022; 9 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 13 of which 8 under generic applications, 7 under brand applications, repackagers included
- Last listed patent
- July 25, 2037 Calcium Gluconate injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2013 0 Class I among all firms' recalls; latest October 19, 2017; 3 more by firms not listed as its makers
- FAERS reports
- 11,976 through July 30, 2026
What is calcium gluconate used for?
From the label: indications and usageCalcium 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.
FDA pharmacologic class: Blood Coagulation Factor and Phosphate Binder.
Source: FDA drug label (Calcium Gluconate), Fresenius Kabi USA, LLC, effective May 6, 2024 (SPL set 7f5101e0-abf9-4fcf-8986-c799e3333434), via openFDA; the full label on DailyMed
Is there a generic for calcium gluconate?
The FDA approved the first generic calcium gluconate on October 14, 2022. 9 generic applications are approved; 9 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists calcium gluconate from 8 labelers under a generic (ANDA) application and from 7 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 1 patent for Calcium Gluconate injection, the last expiring on July 25, 2037. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2017 earliest approval on file
- 2022 first generic approved
- 2037 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has calcium gluconate been recalled?
The FDA's Enforcement Report lists 5 recalls naming calcium gluconate since 2013: 0 Class I (the most serious), 4 Class II, 1 Class III; 0 still ongoing. 3 of them are by firms that FDA's NDC Directory does not list as a maker of calcium gluconate and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| May 18, 2022 | Class II | Nephron Sterile Compounding Center LLC not a listed maker | Lack of Assurance of Sterility |
| August 21, 2018 | Class II | Auro Pharmacies, Inc. not a listed maker | Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile. |
| October 19, 2017 | Class II | SCA Pharmaceuticals, LLC | Lack Of Assurance Of Sterility. |
| October 16, 2015 | Class II | Downing Labs, LLC not a listed maker | Lack of Assurance of Sterility |
| February 1, 2013 | Class III | Fresenius Kabi USA LLC (FK USA) | Labeling: Missing label |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the calcium gluconate label say about other medicines?
The calcium gluconate label names 5 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name calcium gluconate. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Calcipotriene | drug interactions | Vitamin D, vitamin A, thiazide diuretics, estrogen, calcipotriene and teriparatide administration may cause hypercalcemia. |
| Ceftriaxone | contraindications | 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 |
| Digoxin | drug interactions | Hypercalcemia increases the risk of digoxin toxicity, while digoxin may be therapeutically ineffective in the presence of hypocalcemia. |
| Teriparatide | drug interactions | Vitamin D, vitamin A, thiazide diuretics, estrogen, calcipotriene and teriparatide administration may cause hypercalcemia. |
| Vitamin a | drug interactions | Vitamin D, vitamin A, thiazide diuretics, estrogen, calcipotriene and teriparatide administration may cause hypercalcemia. |
Other labels that name calcium gluconate
Source: FDA drug label (Calcium Gluconate), Fresenius Kabi USA, LLC, effective May 6, 2024 (SPL set 7f5101e0-abf9-4fcf-8986-c799e3333434), via openFDA; the full label on DailyMed
What do FAERS reports show for calcium gluconate?
The FDA Adverse Event Reporting System holds 11,976 reports that list calcium gluconate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,530 are coded as a death and 5,555 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other blood coagulation factors
- the pharmacologic class, with prices and generics
- Calcium gluconate side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other