Medicine
Arsenic trioxide 12 mg/6 mL injection
Arsenic trioxide 12 mg/6 mL injection is a generic prescription medicine for intravenous use, made by 9 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°F to 77°F), excursions permitted to…
Key facts
- Active ingredient (INN)
- Arsenic trioxide
- Brand
- Sold under the generic name
- Strength
- 12 mg/6 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 10 vials of 6 mL, 10 cartons of 6 mL, 1 vial of 6 mL and 10 more
- Manufacturers
- Zydus LifesciencesIndiaAvet PharmaceuticalsIndiaEugiaIndiaGland PharmaIndiaOrbicular Pharmaceutical TechnologiesIndiaSandozSinteticaAmneal PharmaceuticalsSagent Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Do not freeze. Store at 20° to 25°C (68°F to 77°F), excursions permitted to 15° to 30°C (59°F to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01XX27 Arsenic trioxide
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 3 September 2019
- Identifiers
- RxCUI 829926, 1992545DailyMed set ID 2cb52683-1e74-4831-a771-55a78536cfe5, e1ad5d87-e65e-402f-86b5-e641fc4e61ab, a9008658-c2dd-49f4-b1c4-26e232c81957 +8NDC 68083-462, 70710-1610, 0781-3498 +8Application ANDA215059, ANDA206228, ANDA215359 +3
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 in 1 carton / 6 mL in 1 vial | 49315-007-10 | Zydus LifesciencesIndia | 3 September 2019 |
| 10 vial in 1 carton / 6 mL in 1 vial | 70710-1610-6 | Zydus LifesciencesIndia | 3 September 2019 |
| 10 vial in 1 carton / 6 mL in 1 vial | 70710-1896-6 | Zydus LifesciencesIndia | 28 February 2023 |
| 10 vial, single-dose in 1 carton / 6 mL in 1 vial, single-dose | 23155-870-41 | Avet PharmaceuticalsIndia | 23 June 2023 |
| 10 carton in 1 carton / 1 vial, single-dose in 1 carton / 6 mL in 1 vial, single-dose | 55150-366-10 | EugiaIndia | 15 October 2021 |
| 10 vial, single-dose in 1 carton / 6 mL in 1 vial, single-dose | 68083-462-10 | Gland PharmaIndia | 7 October 2021 |
| 10 vial, single-dose in 1 carton / 6 mL in 1 vial, single-dose | 81607-006-07 | Orbicular Pharmaceutical TechnologiesIndia | 31 May 2023 |
| 10 vial, single-dose in 1 carton / 6 mL in 1 vial, single-dose | 70121-1658-1 | Amneal Pharmaceuticals | 20 August 2021 |
| 10 vial in 1 carton / 6 mL in 1 vial | 25021-227-06 | Sagent Pharmaceuticals | 15 February 2023 |
| 1 vial in 1 carton / 6 mL in 1 vial | 0781-3498-94 | Sandoz | 19 May 2022 |
| 10 vial in 1 carton / 6 mL in 1 vial | 0781-3498-95 | Sandoz | 19 May 2022 |
| 1 vial, single-dose in 1 carton / 6 mL in 1 vial, single-dose | 83090-010-01 | Sintetica | 9 November 2023 |
| 10 vial, single-dose in 1 carton / 6 mL in 1 vial, single-dose | 83090-010-10 | Sintetica | 9 November 2023 |
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.
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 Arsenic trioxide 12 mg/6 mL injection.
Other strengths and forms of Arsenic trioxide
Clinical summary
Arsenic trioxide is a prescription medicine indicated in combination with tretinoin for treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL), among other approved uses. MedsAcross supplies Arsenic trioxide 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 Arsenic trioxideFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Trisenox prescribing information (Cephalon) · U.S. National Library of Medicine, DailyMed
- Trisenox: European public assessment report (EPAR) · European Medicines Agency
- Arsenic trioxide Accord: European public assessment report (EPAR) · European Medicines Agency
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