Medicine
Pentamidine 300 mg/300 mg powder for injection
Pentamidine 300 mg/300 mg powder for injection is a generic prescription medicine for intramuscular, intravenous use, made by 2 labelers, 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.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store dry product at 20° to 25°C (68° to 77°F). Protect from light.
Key facts
- Active ingredient (INN)
- Pentamidine
- Brand
- Sold under the generic name
- Strength
- 300 mg/300 mg
- Dosage form
- Powder for injection
- Route
- Intramuscular, intravenous
- Packs
- 10 vials
- Manufacturers
- Avet PharmaceuticalsIndiaSeton Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store dry product at 20° to 25°C (68° to 77°F). Protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 April 2018
- Identifiers
- RxCUI 861601DailyMed set ID cb8e8155-5505-44d5-9dee-525e2e45b95d, 5c14fbf2-e21f-44b3-b35c-06919d40d7e0NDC 13925-515, 23155-748Application ANDA206666, ANDA213806
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
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 10 vial, single-dose in 1 carton / 300 mg in 1 vial, single-dose | 23155-748-41 | Avet PharmaceuticalsIndia | 8 January 2021 |
| 10 vial in 1 tray / 300 mg in 1 vial | 13925-515-10 | Seton Pharmaceuticals | 1 April 2018 |
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 16 October 1984 | 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 Pentamidine
Clinical summary
Pentamidine is an antiprotozoal indicated for the treatment of pneumonia due to Pneumocystis carinii. It is available as inhalant and powder for injection for inhalation, intramuscular and intravenous use. MedsAcross supplies Pentamidine 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 PentamidineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Pentam 300 prescribing information (Fresenius Kabi) · U.S. National Library of Medicine, DailyMed
Need Pentamidine 300 mg/300 mg 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.