Quick answers
- What is Caspofungin acetate used for?
- The FDA-approved label (Caspofungin Acetate, Fresenius Kabi USA, LLC, January 8, 2026) says: “Caspofungin acetate for Injection is an echinocandin antifungal indicated in adults and pediatric patients (3 months of age and older) for: • Empirical therapy for presumed fungal infections in febrile, neutropenic patients. • Treatment of candidemia and the following Candida infections: intra-abdominal abscesses, peritonitis and pleural space infections. • Treatment of esophageal candidiasis. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Caspofungin acetate have a boxed warning?
- No. None of the 6 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Caspofungin acetate?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated June 30, 2026). Ask your pharmacist about alternatives.
- Has Caspofungin acetate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Caspofungin acetate?
- 7 companies list prescription products of Caspofungin acetate in the FDA NDC Directory, including Fosun Pharma USA Inc., Merck Sharp & Dohme LLC and Fresenius Kabi USA, LLC.
What Caspofungin acetate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Caspofungin acetate for Injection is an echinocandin antifungal indicated in adults and pediatric patients (3 months of age and older) for: • Empirical therapy for presumed fungal infections in febrile, neutropenic patients. • Treatment of candidemia and the following Candida infections: intra-abdominal abscesses, peritonitis and pleural space infections. • Treatment of esophageal candidiasis. …
— FDA label: Caspofungin Acetate, Fresenius Kabi USA, LLC, effective January 8, 2026. Read the full label on DailyMed →
The FDA has 6 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 6 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, powder, lyophilized, for solution |
|---|---|
| Route | Intravenous |
| Prescription products | 14 in the FDA NDC Directory |
| Brand names | Cancidas |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Fosun Pharma USA Inc.2 products
- Merck Sharp & Dohme LLC2 products
- Fresenius Kabi USA, LLC2 products
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.2 products
- Gland Pharma Limited2 products
- Sandoz Inc2 products
- Sagent Pharmaceuticals2 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021227 CANCIDAS | Merck | January 26, 2001 | 30, latest October 25, 2021 2021: Labeling · 2019: Labeling · 2018: Labeling |
| NDA206110 CASPOFUNGIN ACETATE | Fresenius Kabi USA | December 30, 2016 | 2, latest April 1, 2021 2021: Labeling · 2018: Labeling |
Generic approvals (3)
- ANDA207092Gland · September 29, 2017
- ANDA200833Hengrui Pharma · June 28, 2018
- ANDA216506Hangzhou Zhongmei · July 18, 2025
Shortage status
To be discontinued · updated June 30, 2026 · first posted June 30, 2026
| Product | Caspofungin Acetate, Injection, 7 mg/1 mL (NDC 0781-3423-94) |
|---|---|
| Company | Jiangsu Hengrui Pharmaceuticals Co. (US Agent eVenus Pharmaceutical Laboratories, Inc.) |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 828539, 828755 |
|---|---|
| SPL set ID of the quoted label | e76d8d83-3691-451c-a32c-d91448c54d16 |
| FDA labels (SPL) | 6 |
| FDA applications | NDA021227, NDA206110, 3 ANDA |
| Active ingredients (FDA) | CASPOFUNGIN ACETATE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Caspofungin Acetate, Fresenius Kabi USA, LLC, effective January 8, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →