Prescription medicine

Amphotericin b First approved as Fungizone

Amphotericin b (Fungizone) is a prescription medicine with an FDA approval on record since 1965. FDA's NDC Directory lists it from 5 generic labelers.

Generic listed

Check it at the source: the amphotericin b FDA label on DailyMed (effective June 3, 2025, Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.); the NDA 50313 record on Drugs@FDA; every amphotericin b label on DailyMed.

Highlights of the record

FDA label of June 3, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage
Amphotericin B liposome for injection is indicated for the following: Empirical therapy for presumed fungal infection in febrile, neutropenic patients.

Forms and strengths

50 mg
50 mg/12.5ml
50 mg/10ml

Injectable (liposomal); injection (powder) (lyophilized) for solution; injection (powder) (lyophilized) for suspension.

On the market

Earliest approval on file: October 13, 1965 Fungizone, Apothecon; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: 10 first November 12, 1964; 5 with a marketed status in Drugs@FDA
Labelers listed (NDC): 5 of which 5 under generic applications, 0 under brand applications, repackagers included

Supply and safety

Pharmacy cost (NADAC): Not in the survey
Shortage (FDA): No current entry
Recalls by its makers (FDA): 1 since 2012 0 Class I among all firms' recalls; latest April 19, 2024; 1 more by firms not listed as its makers
FAERS reports: 14,762 through July 30, 2026

What is amphotericin b used for?

From the label: indications and usage
Amphotericin B liposome for injection is indicated for the following: Empirical therapy for presumed fungal infection in febrile, neutropenic patients. Treatment of Cryptococcal Meningitis in HIV-infected patients (see DESCRIPTION OF CLINICAL STUDIES ). Treatment of patients with Aspergillus species, Candida species and/or Cryptococcus species infections (see above for the treatment of Cryptococcal Meningitis) refractory to amphotericin B deoxycholate, or in patients where renal impairment or unacceptable toxicity precludes the use of amphotericin B deoxycholate. Treatment of visceral leishmaniasis. […]

Conditions named in the indications of amphotericin b's FDA labels, with every medicine labeled for each:

Fungal infections

FDA pharmacologic class: Lipid-based Polyene Antifungal and Polyene Antifungal.

Source: FDA drug label (Amphotericin B), Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., effective June 3, 2025 (SPL set 2b2f3ff5-9d62-4ad2-8eac-1181e5911513), via openFDA; the full label on DailyMed

Is there a generic for amphotericin b (Fungizone)?

The FDA approved the first generic amphotericin b on November 12, 1964. 10 generic applications are approved; 5 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.

FDA's NDC Directory lists amphotericin b from 5 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.

1965 earliest approval on file
1964 first generic approved
red ticks recalls

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

Has amphotericin b been recalled?

The FDA's Enforcement Report lists 2 recalls naming amphotericin b since 2012: 0 Class I (the most serious), 2 Class II, 0 Class III; 1 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of amphotericin b and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.

Started	Class	Company	Reason
April 19, 2024	Class II	SUN PHARMACEUTICAL INDUSTRIES INC	Out of specification for assay
May 25, 2012	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab not a listed maker	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA …

Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026

What does the amphotericin b label say about other medicines?

The amphotericin b label names no other medicine on this site. The labels of 26 other medicines name amphotericin b. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Other labels that name amphotericin b

Check amphotericin b against other medicines

What do FAERS reports show for amphotericin b?

The FDA Adverse Event Reporting System holds 14,762 reports that list amphotericin b among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 5,701 are coded as a death and 6,302 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

Reports received each year

The most reported reactions

Drug Ineffective (a use or a product term, not a reaction)4,098
Off Label Use (a use or a product term, not a reaction)1,759
Condition Aggravated (a use or a product term, not a reaction)815
Pyrexia795
Product Use In Unapproved Indication (a use or a product term, not a reaction)534
Multiple Organ Dysfunction Syndrome530
Acute Kidney Injury529
Sepsis (named in the label)480

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What else is labeled for the same conditions as amphotericin b?

6 other medicines are given the same way (intravenous) and in the same FDA class as amphotericin b or labeled mainly for the same use (fungal infections), the same class first. Fungal infections lists all 33 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.

Medicine	Shared indication	Generic labelers (intravenous)	Pharmacy cost	Shortage
Micafungin	Fungal infections	10 labelers	n/a	A presentation being discontinued
Voriconazole	Fungal infections	12 labelers	n/a	A presentation being discontinued
Caspofungin	Fungal infections	5 labelers	n/a	A presentation being discontinued
Fluconazole	Fungal infections	4 labelers	n/a	No current entry
Posaconazole	Fungal infections	7 labelers	n/a	A presentation being discontinued
Anidulafungin	Fungal infections	none listed	n/a	No current entry

Every medicine labeled for the same conditions as amphotericin b

Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)

What next?

Alternatives to amphotericin b: 6 medicines for the same use
Other polyene antifungals: the pharmacologic class, with prices and generics
Amphotericin b side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other