Medicine
Amikacin 1000 mg/4 mL injection
Amikacin 1000 mg/4 mL injection is a generic prescription medicine for intramuscular, intravenous use, made by 6 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). *Discard unused portion.
Key facts
- Active ingredient (INN)
- Amikacin
- Brand
- Sold under the generic name
- Strength
- 1000 mg/4 mL
- Dosage form
- Injection
- Route
- Intramuscular, intravenous
- Packs
- 10 vials of 4 mL and 4 more
- Manufacturers
- Avet PharmaceuticalsIndiaFresenius KabiHikma PharmaceuticalsMullan PharmaceuticalQilu PharmaceuticalSagent Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F). *Discard unused portion.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- D06AX12 Amikacin
- HS code (indicative)
- 3004.20Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 24 December 2013
- Identifiers
- RxCUI 1723156, 1723160DailyMed set ID f260ff2a-76a0-4672-9516-91c344b67890, c0f57839-1c9b-49e5-8c7a-708e2d16495d, 0b56f6df-a05d-4520-8bf0-d7cefe20f6ad +4NDC 25021-173, 63323-815, 0641-6166 +4Application ANDA203323, ANDA205604, ANDA063315 +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, glass in 1 carton / 4 mL in 1 vial, glass | 23155-290-42 | Avet PharmaceuticalsIndia | 24 December 2013 |
| 10 vial, glass in 1 carton / 4 mL in 1 vial, glass | 23155-786-41 | Avet PharmaceuticalsIndia | 15 December 2020 |
| 10 vial, single-dose in 1 carton / 4 mL in 1 vial, single-dose | 63323-815-04 | Fresenius Kabi | 9 December 2015 |
| 10 vial in 1 carton / 4 mL in 1 vial | 0641-6166-10 | Hikma Pharmaceuticals | 1 August 2015 |
| 10 vial, single-dose in 1 carton / 4 mL in 1 vial, single-dose | 83301-0023-2 | Mullan Pharmaceutical | 12 January 2026 |
| 10 vial, glass in 1 carton / 4 mL in 1 vial, glass | 67184-0570-2 | Qilu Pharmaceutical | 19 March 2024 |
| 10 vial in 1 carton / 4 mL in 1 vial | 25021-173-04 | Sagent Pharmaceuticals | 15 June 2016 |
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
Other strengths and forms of Amikacin
Clinical summary
Amikacin is an aminoglycoside antibacterial indicated in adults, who have limited or no alternative treatment options, among other approved uses. It is available as injection and inhalation suspension for intramuscular and intravenous use. MedsAcross supplies Amikacin 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 AmikacinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- ARIKAYCE prescribing information (Insmed) · U.S. National Library of Medicine, DailyMed
- Arikayce liposomal: European public assessment report (EPAR) · European Medicines Agency
Need Amikacin 1000 mg/4 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.