Medicine
Amphotericin b 50 mg/10 mL powder for injection
Amphotericin b 50 mg/10 mL powder for injection 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. It ships in a temperature-controlled cold chain.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
Prior to reconstitution Amphotericin B for Injection USP should be stored…
Key facts
- Active ingredient (INN)
- Amphotericin b
- Brand
- Sold under the generic name
- Strength
- 50 mg/10 mL
- Dosage form
- Powder for injection
- Route
- Intravenous
- Packs
- 10 mL
- Manufacturer
- XGen Pharmaceuticals DJB
- Origin register
- US FDA, United States
- Storage
- Prior to reconstitution Amphotericin B for Injection USP should be stored under refrigeration, 2˚ to 8˚C (36˚to 46˚F), protected against exposure to light. The concentrate (5 mg amphotericin B per mL after reconstitution with 10 mL Sterile Water for Injection USP) may be stored in the dark, at room temperature for 24 hours, or at refrigerator temperatures for one week with minimal loss of potency…
- Cold chain
- Yes, shipped temperature controlled
- 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
- 29 April 1992
- Identifiers
- RxCUI 239240DailyMed set ID a0a54943-9ce4-4f3e-b681-a1a9144c16ceNDC 39822-1055Application ANDA063206
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 |
|---|---|---|---|
| 10 mL in 1 vial | 39822-1055-5 | XGen Pharmaceuticals DJB | 29 April 1992 |
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/10 mL powder for 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.