Medicine
Ketamine 500 mg/10 mL injection
Ketamine 500 mg/10 mL injection is a generic prescription medicine for intramuscular, intravenous use, made by 7 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
Ketamine Hydrochloride Injection, USP should be stored at 20°C to 25°C (68°F…
Key facts
- Active ingredient (INN)
- Ketamine
- Brand
- Sold under the generic name
- Strength
- 500 mg/10 mL
- Dosage form
- Injection
- Route
- Intramuscular, intravenous
- Packs
- 10 vials of 10 mL and 4 more
- Manufacturers
- EugiaIndiaGland PharmaIndiaCivicaFresenius KabiHikma PharmaceuticalsHospiraSagent Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Ketamine Hydrochloride Injection, USP should be stored at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F). Protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Schedule CIII
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 July 1996
- Identifiers
- RxCUI 238083, 238084, 238082DailyMed set ID 58c86d9b-8694-4bd8-8254-f19ee3ad60b0, b96a0a23-3ca0-4a92-bd8b-1e9921931772, bb912318-2e22-4469-b0a2-774803ee1bb8 +3NDC 72572-320, 68083-505, 0409-2053 +4Application ANDA074524, ANDA216809, ANDA074549 +2
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 |
|---|---|---|---|
| 10 vial, multi-dose in 1 carton / 10 mL in 1 vial, multi-dose | 55150-439-10 | EugiaIndia | 15 March 2021 |
| 10 vial in 1 carton / 10 mL in 1 vial | 68083-505-10 | Gland PharmaIndia | 24 January 2023 |
| 10 vial in 1 tray / 10 mL in 1 vial | 65219-188-10 | Fresenius Kabi | 10 July 2023 |
| 10 vial in 1 box / 10 mL in 1 vial | 0143-9508-10 | Hikma Pharmaceuticals | 1 July 1996 |
| 10 vial, multi-dose in 1 box / 10 mL in 1 vial, multi-dose | 0409-2053-10 | Hospira | 30 November 2004 |
| 10 vial in 1 carton / 10 mL in 1 vial | 25021-683-10 | Sagent Pharmaceuticals | 15 July 2023 |
| 10 vial in 1 box / 10 mL in 1 vial | 72572-320-10 | Civica | 5 December 2019 |
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 19 February 1970 | 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
Alternatives
Other makers and brands of Ketamine 500 mg/10 mL injection.
Other strengths and forms of Ketamine
Clinical summary
Ketamine is a general anesthetic indicated for diagnostic and surgical procedures that do not require skeletal muscle relaxation. It is available as injection for intramuscular and intravenous use. MedsAcross supplies Ketamine 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 KetamineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Ketalar prescribing information (Par Health) · U.S. National Library of Medicine, DailyMed
Need Ketamine 500 mg/10 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.