Medicine
Amiodarone 450 mg/9 mL injection
Amiodarone 450 mg/9 mL injection is a generic prescription medicine for intravenous use, made by 5 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
Store at 20° to 25°C (68° to 77°F). Protect from light and excessive heat.
Key facts
- Active ingredient (INN)
- Amiodarone
- Brand
- Sold under the generic name
- Strength
- 450 mg/9 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 10 vials of 9 mL, 9 mL and 4 more
- Manufacturers
- AuroMedics PharmaIndiaFresenius KabiMylan InstitutionalSlate Run PharmaceuticalsZhejiang Poly Pharm
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F). Protect from light and excessive heat.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C01BD01 Amiodarone
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 14 October 2002
- Identifiers
- RxCUI 833532, 1663224, 1663244 +1DailyMed set ID 6cd870d7-6381-421a-89bc-bce5c9518219, d8d04647-8e25-4127-8ecf-360ce1991c2f, 9772ab48-2ef1-4b9f-9a27-794f3e7e5c7a +4NDC 55150-181, 63323-616, 65219-645 +4Application ANDA204550, ANDA075761, ANDA076217 +1
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, single-dose in 1 carton / 9 mL in 1 vial, single-dose | 55150-181-09 | AuroMedics PharmaIndia | 25 October 2017 |
| 10 vial, single-dose in 1 tray / 9 mL in 1 vial, single-dose | 63323-616-09 | Fresenius Kabi | 28 January 2003 |
| 10 vial, single-dose in 1 tray / 9 mL in 1 vial, single-dose | 65219-645-09 | Fresenius Kabi | 5 May 2025 |
| 10 vial, glass in 1 carton / 9 mL in 1 vial, glass | 67457-153-09 | Mylan Institutional | 5 January 2004 |
| 10 vial, glass in 1 carton / 9 mL in 1 vial, glass | 72078-046-09 | Mylan Institutional | 9 June 2023 |
| 10 vial in 1 carton / 9 mL in 1 vial | 70436-232-62 | Slate Run Pharmaceuticals | 31 October 2024 |
| 9 mL in 1 vial, glass | 72673-072-10 | Zhejiang Poly Pharm | 6 February 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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 24 December 1985 | 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 Amiodarone
Clinical summary
Amiodarone is an antiarrhythmic indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients refractory to other therapy. MedsAcross supplies Amiodarone 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 AmiodaroneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Nexterone prescribing information (Baxter Healthcare) · U.S. National Library of Medicine, DailyMed
Need Amiodarone 450 mg/9 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.