Medicine
Amphotericin b 50 mg/12.5 mL powder for injectable suspension
Amphotericin b 50 mg/12.5 mL powder for injectable suspension is a generic prescription medicine for intravenous use, 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
Storage as on the product label
Key facts
- Active ingredient (INN)
- Amphotericin b
- Brand
- Sold under the generic name
- Strength
- 50 mg/12.5 mL
- Dosage form
- Powder for injectable suspension
- Route
- Intravenous
- Packs
- 1 vial
- Manufacturer
- Mylan Institutional
- Origin register
- US FDA, United States
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A01AB04 Amphotericin b
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 6 August 2025
- Identifiers
- RxCUI 967385DailyMed set ID a96a734f-d1c4-4d42-93c2-7c336da7f7b9NDC 67457-926Application ANDA212967
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 vial, single-dose in 1 carton / 12.5 mL in 1 vial, single-dose | 67457-926-50 | Mylan Institutional | 6 August 2025 |
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 13 October 1965 | 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 Amphotericin b
Clinical summary
Amphotericin b is a lipid-based polyene antifungal indicated for the following. It is available as liposomal injection, powder for injection and powder for injectable suspension for intravenous use. MedsAcross supplies Amphotericin b 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 Amphotericin bFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Amphotericin B prescribing information (Sun Pharmaceutical Industries) · U.S. National Library of Medicine, DailyMed
Need Amphotericin b 50 mg/12.5 mL powder for injectable suspension 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.