Active ingredient
Pentamidine
9 finished FDA listings contain Pentamidine as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- PENTAMIDINE DIISETHIONATE, PENTAMIDINE ISETHIONATE
- Dosage forms
- Inhalant, Injection, Powder, Lyophilized, For Solution
- Routes
- Intramuscular, Intravenous, Respiratory (Inhalation)
- Manufacturers / labelers
- 5
- Strengths listed
- 300 mg/300mg · 300 mg/3ml · 300 mg/6ml
- Brand names in FDA listings
- Nebupent, Pentam 300
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 7994
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 019264 | FRESENIUS KABI USA | 1984-10-16 | 1 |
| NDA 019887 | FRESENIUS KABI USA | 1989-06-15 | 1 |
| ANDA 206666 | PAI HOLDINGS | 2017-09-28 | 2 |
| ANDA 206667 | PAI HOLDINGS | 2019-04-24 | 2 |
| ANDA 213806 | AVET LIFESCIENCES | 2021-01-07 | 1 |
| ANDA 206982 | PHARMOBEDIENT | 2022-03-17 | 1 |
| ANDA 206983 | X-GEN PHARMS INC | 2023-01-20 | 1 |
Official labeling on DailyMed
- PENTAMIDINE ISETHIONATE INHALANT [PAI HOLDINGS, LLC DBA PAI PHARMA] · version 2 · 2026-06-15
- PENTAMIDINE ISETHIONATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA] · version 1 · 2026-06-15
- PENTAMIDINE ISETHIONATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.] · version 7 · 2025-11-17
- PENTAMIDINE ISETHIONATE INHALANT [SETON PHARMACEUTICALS] · version 6 · 2025-04-10
- PENTAMIDINE ISETHIONATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SETON PHARMACEUTICALS] · version 8 · 2025-04-07
- NEBUPENT (PENTAMIDINE ISETHIONATE) INHALANT [FRESENIUS KABI USA, LLC] · version 4 · 2024-10-21
- PENTAMIDINE ISETHIONATE INHALANT [XGEN PHARMACEUTICALS DJB, INC.] · version 6 · 2024-03-20
- PENTAMIDINE ISETHIONATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [XGEN PHARMACEUTICALS DJB, INC.] · version 6 · 2024-02-02
- PENTAM 300 (PENTAMIDINE ISETHIONATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] · version 3 · 2022-09-19
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.