Quick answers
- What is Pentamidine used for?
- The FDA-approved label (Pentam 300, Fresenius Kabi USA, LLC, September 13, 2022) says: “Pentam 300 (pentamidine isethionate for injection) is indicated for the treatment of pneumonia due to Pneumocystis carinii.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Pentamidine have a boxed warning?
- No. None of the 7 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Pentamidine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Pentamidine been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Pentamidine?
- 5 companies list prescription products of Pentamidine in the FDA NDC Directory, including Seton Pharmaceuticals, Fresenius Kabi USA, LLC and PAI Holdings, LLC dba PAI Pharma.
What Pentamidine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Pentam 300 (pentamidine isethionate for injection) is indicated for the treatment of pneumonia due to Pneumocystis carinii.
— FDA label: Pentam 300, Fresenius Kabi USA, LLC, effective September 13, 2022. Read the full label on DailyMed →
The FDA has 7 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.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
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 7 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Inhalant · Injection, powder, lyophilized, for solution |
|---|---|
| Route | Respiratory (inhalation) · Intramuscular · Intravenous |
| Prescription products | 8 in the FDA NDC Directory |
| Brand names | Pentam 300, Nebupent |
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.
- Seton Pharmaceuticals2 products
- Fresenius Kabi USA, LLC2 products
- PAI Holdings, LLC dba PAI Pharma2 products
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.1 product
- XGen Pharmaceuticals DJB, Inc.1 product
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 |
|---|---|---|---|
| NDA019264 PENTAM | Fresenius Kabi USA | October 16, 1984 | 19, latest January 8, 2014 2014: Manufacturing (CMC) · 2013: Manufacturing (CMC) · 2002: Manufacturing (CMC) |
| NDA019887 NEBUPENT | Fresenius Kabi USA | June 15, 1989 | 8, latest February 16, 2013 2013: Manufacturing (CMC) · 2011: Labeling · 1996: Labeling |
Generic approvals (4)
- ANDA206666Pai Holdings · September 28, 2017
- ANDA206667Pai Holdings · April 24, 2019
- ANDA213806Avet Lifesciences · January 7, 2021
- ANDA206983X-Gen Pharms Inc · January 20, 2023
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 861597, 861599, 861601, 861604 |
|---|---|
| SPL set ID of the quoted label | cc2b635e-4840-4dc3-a177-5484371680e8 |
| FDA labels (SPL) | 7 |
| FDA applications | NDA019264, NDA019887, 4 ANDA |
| Active ingredients (FDA) | PENTAMIDINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Pentam 300, Fresenius Kabi USA, LLC, effective September 13, 2022; 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 →