Medicine
Argatroban 50 mg/50 mL injection
Argatroban 50 mg/50 mL injection is a generic prescription medicine for intravenous use, made by 8 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 the vials in original carton at 20° to 25°C (68° to…
Key facts
- Active ingredient (INN)
- Argatroban
- Brand
- Sold under the generic name
- Strength
- 50 mg/50 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 1 vial of 50 mL, 10 vials of 50 mL and 9 more
- Manufacturers
- Accord HealthcareIndiaEugiaIndiaCaplin SterilesIndiaGland PharmaIndiaHikma PharmaceuticalsMullan PharmaceuticalFresenius KabiSagent Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Do not freeze. Store the vials in original carton at 20° to 25°C (68° to 77°F). Retain in the original carton to protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 November 2016
- Identifiers
- RxCUI 1804735, 308351DailyMed set ID 50e21062-f021-40f2-ad11-896f46378a15, 46cdf9e6-839c-49c8-9ee1-c30cfdd9368d, 629aee90-3bf3-4947-a978-21cbba2e1c41 +7NDC 83301-0062, 16729-430, 25021-414 +7Application ANDA217848, NDA212035, ANDA214235 +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 |
|---|---|---|---|
| 1 vial, single-use in 1 carton / 50 mL in 1 vial, single-use | 16729-430-11 | Accord HealthcareIndia | 7 October 2021 |
| 10 vial, single-use in 1 carton / 50 mL in 1 vial, single-use | 16729-430-43 | Accord HealthcareIndia | 7 October 2021 |
| 1 vial in 1 carton / 50 mL in 1 vial | 65145-126-01 | Caplin SterilesIndia | 17 April 2026 |
| 1 vial, single-dose in 1 carton / 50 mL in 1 vial, single-dose | 55150-241-01 | EugiaIndia | 27 November 2018 |
| 10 vial, single-dose in 1 carton / 50 mL in 1 vial, single-dose | 55150-241-10 | EugiaIndia | 27 November 2018 |
| 1 vial in 1 carton / 50 mL in 1 vial | 68083-568-01 | Gland PharmaIndia | 31 July 2023 |
| 1 vial in 1 carton / 50 mL in 1 vial | 0143-9377-01 | Hikma Pharmaceuticals | 25 March 2020 |
| 1 vial in 1 carton / 50 mL in 1 vial | 0143-9559-01 | Hikma Pharmaceuticals | 1 November 2016 |
| 1 vial, single-dose in 1 carton / 50 mL in 1 vial, single-dose | 83301-0062-1 | Mullan Pharmaceutical | 10 March 2026 |
| 1 vial, single-dose in 1 carton / 50 mL in 1 vial, single-dose | 83301-0500-1 | Mullan Pharmaceutical | 1 January 2026 |
| 1 vial in 1 carton / 50 mL in 1 vial | 65219-429-50 | Fresenius Kabi | 24 May 2021 |
| 1 vial in 1 carton / 50 mL in 1 vial | 25021-414-50 | Sagent Pharmaceuticals | 15 April 2021 |
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 30 June 2000 | 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 Argatroban
Clinical summary
Argatroban is an anti-coagulant indicated for prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT), among other approved uses. It is available as injection for intravenous use. MedsAcross supplies Argatroban 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 ArgatrobanFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Argatroban prescribing information (Plano Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Argatroban 50 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.