Medicine
Argatroban 125 mg/125 mL injection
Argatroban 125 mg/125 mL injection is a generic prescription medicine for intravenous use, made by 2 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 cartons at 20º to 25ºC (68º to…
Key facts
- Active ingredient (INN)
- Argatroban
- Brand
- Sold under the generic name
- Strength
- 125 mg/125 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 2 vials of 125 mL
- Manufacturers
- Gland PharmaIndiaPlano Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Do not freeze. Store the vials in original cartons at 20º to 25ºC (68º 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
- 9 May 2011
- Identifiers
- RxCUI 1804737DailyMed set ID e5ccb93c-f411-4e7e-824a-4a592b4947ec, 514ad15b-d060-9d65-e063-6294a90a6188NDC 68083-141, 87188-104Application ANDA205570, NDA022485
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 |
|---|---|---|---|
| 2 vial in 1 carton / 125 mL in 1 vial | 68083-141-02 | Gland PharmaIndia | 26 May 2017 |
| 2 vial, single-use in 1 carton / 125 mL in 1 vial, single-use | 87188-104-90 | Plano Pharmaceuticals | 9 May 2011 |
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 125 mg/125 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.