Quick answers
- What is Calcium gluconate used for?
- The FDA-approved label (Calcium Gluconate, Fresenius Kabi USA, LLC, May 18, 2026) says: “Calcium Gluconate Injection is indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia. Calcium Gluconate Injection is a form of calcium 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. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Calcium gluconate have a boxed warning?
- No. None of the 20 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Calcium gluconate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Calcium gluconate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Calcium gluconate?
- 13 companies list prescription products of Calcium gluconate in the FDA NDC Directory, including Amneal Pharmaceuticals Private Limited, WG Critical Care, LLC and Fresenius Kabi USA, LLC.
What Calcium gluconate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Calcium Gluconate Injection is indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia. Calcium Gluconate Injection is a form of calcium 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. …
— FDA label: Calcium Gluconate, Fresenius Kabi USA, LLC, effective May 18, 2026. Read the full label on DailyMed →
The FDA has 20 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 20 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution |
|---|---|
| Route | Intravenous |
| Prescription products | 33 in the FDA NDC Directory |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Amneal Pharmaceuticals Private Limited8 products
- WG Critical Care, LLC6 products
- Fresenius Kabi USA, LLC4 products
- Hikma Pharmaceuticals USA Inc.3 products
- Caplin Steriles Limited3 products
- Glenmark Pharmaceuticals Inc., USA3 products
- Remedyrepack Inc.2 products
- Henry Schein, Inc.2 products
- HF Acquisition Co LLC, DBA HealthFirst2 products
- Somerset Therapeutics, LLC2 products
- Medical Purchasing Solutions, LLC1 product
- ProPharma Distribution1 product
- B. Braun Medical Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA208418 CALCIUM GLUCONATE, CALCIUM GLUCONATE IN SODIUM CHLORIDE | Fresenius Kabi USA | June 15, 2017 | 4, latest October 17, 2022 2022: Labeling · 2021: Labeling · 2021: Labeling |
| NDA210906 CALCIUM GLUCONATE, CALCIUM GLUCONATE IN SODIUM CHLORIDE | Hq Spclt Pharma | October 29, 2018 | 1, latest October 28, 2020 2020: Labeling |
Generic approvals (6)
- ANDA213071Nivagen · October 14, 2022
- ANDA216541B Braun Medical · August 21, 2023
- ANDA217174Amneal · September 5, 2023
- ANDA217689Somerset · October 19, 2023
- ANDA216611Amneal · May 10, 2024
- ANDA218840Caplin · May 4, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Calcium Gluconate, Fresenius Kabi USA, LLC, effective May 18, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →