Medicine
Pentam 300 300 mg/3 mL powder for injection
Pentam 300 300 mg/3 mL powder for injection is a prescription medicine containing Pentamidine for intramuscular, intravenous use, marketed by Fresenius Kabi, 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
- Pentam 300
- Strength
- 300 mg/3 mL
- Dosage form
- Powder for injection
- Route
- Intramuscular, intravenous
- Packs
- 10 vials
- Marketing authorisation holder
- Fresenius Kabi
- Manufacturer
- Fresenius Kabi
- 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
- 16 January 2001
- Identifiers
- RxCUI 861601, 861604DailyMed set ID cc2b635e-4840-4dc3-a177-5484371680e8NDC 63323-113Application NDA019264
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 10 vial in 1 tray / 3 mL in 1 vial | 63323-113-10 | Fresenius Kabi | 16 January 2001 |
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 Pentam 300 300 mg/3 mL 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.