Medicine
Alprostadil 500 mcg/1 mL injection
Alprostadil 500 mcg/1 mL injection is a generic prescription medicine for intravascular use, 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. It ships in a temperature-controlled cold chain.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
Store alprostadil injection, USP in a refrigerator at 2° to 8°C (36° to 46°F).
Key facts
- Active ingredient (INN)
- Alprostadil
- Brand
- Sold under the generic name
- Strength
- 500 mcg/1 mL
- Dosage form
- Injection
- Route
- Intravascular
- Packs
- 10 vials of 1 mL
- Manufacturer
- Meitheal Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store alprostadil injection, USP in a refrigerator at 2° to 8°C (36° to 46°F).
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C01EA01 Alprostadil
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 15 September 2024
- Identifiers
- RxCUI 237212DailyMed set ID 35d229e1-6947-435c-bf54-bfa09cca7e53NDC 71288-206Application ANDA075196
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, single-use in 1 carton / 1 mL in 1 vial, single-use | 71288-206-02 | Meitheal Pharmaceuticals | 15 September 2024 |
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 1981 | 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
Alternatives
Other makers and brands of Alprostadil 500 mcg/1 mL injection.
Other strengths and forms of Alprostadil
Clinical summary
Alprostadil is a prostaglandin analog indicated for palliative, not definitive, therapy to temporarily maintain the patency of the ductus arteriosus until corrective or palliative surgery can be performed in neonates, among other approved uses. MedsAcross supplies Alprostadil 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 AlprostadilFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- PROSTIN VR PEDIATRIC prescribing information (Pharmacia & Upjohn) · U.S. National Library of Medicine, DailyMed
Need Alprostadil 500 mcg/1 mL 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.