Medicine
Calcium gluconate 5000 mg/50 mL injection
Calcium gluconate 5000 mg/50 mL injection is a generic prescription medicine for intravenous use, made by 3 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Do not freeze. Store at 20° to 25°C (68° to 77°F). The precipitate, if…
Key facts
- Active ingredient (INN)
- Calcium gluconate
- Brand
- Sold under the generic name
- Strength
- 5000 mg/50 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 25 vials of 50 mL
- Manufacturers
- Caplin SterilesIndiaGlenmark PharmaceuticalsIndiaFresenius Kabi
- Origin register
- US FDA, United States
- Storage
- Do not freeze. Store at 20° to 25°C (68° to 77°F). The precipitate, if present, may be dissolved by warming the vial to 60° to 80°C, with occasional agitation, until the solution becomes clear. Allow to cool to room temperature before dispensing.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A12AA03 Calcium gluconate
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 15 June 2017
- Identifiers
- RxCUI 197435, 1668248, 1668250DailyMed set ID f28e9871-d546-4b48-ac3d-aead0d4c0449, b2470072-f443-4596-ae33-1b8b0d05bc9d, 8b77c3d2-992d-4261-8421-9cfd07328fbfNDC 65145-171, 68462-790, 63323-360Application ANDA218840, NDA208418
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 25 vial, plastic in 1 carton / 50 mL in 1 vial, plastic | 65145-171-25 | Caplin SterilesIndia | 13 May 2026 |
| 25 vial, plastic in 1 carton / 50 mL in 1 vial, plastic | 68462-790-25 | Glenmark PharmaceuticalsIndia | 4 May 2026 |
| 25 vial, plastic in 1 tray / 50 mL in 1 vial, plastic | 63323-360-59 | Fresenius Kabi | 15 June 2017 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 15 June 2017 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Calcium gluconate
Clinical summary
Calcium gluconate is a blood coagulation factor indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia. It is available as injection for intravenous use. MedsAcross supplies Calcium gluconate for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about Calcium gluconateFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Calcium Gluconate prescribing information (Fresenius Kabi) · U.S. National Library of Medicine, DailyMed
Need Calcium gluconate 5000 mg/50 mL injection for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.