Medicine
Edex 40 mcg/mL powder for injection
Edex 40 mcg/mL powder for injection is a prescription medicine containing Alprostadil for intracavernous use, marketed by Endo, 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 at 25°C (77°F), excursions permitted between 15°C - 30°C (59°F - 86°F).
Key facts
- Active ingredient (INN)
- Alprostadil
- Brand
- Edex
- Strength
- 40 mcg/mL
- Dosage form
- Powder for injection
- Route
- Intracavernous
- Packs
- 2 blister pack, 6 blister pack
- Marketing authorisation holder
- Endo
- Manufacturer
- Endo
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F), excursions permitted between 15°C - 30°C (59°F - 86°F).
- Cold chain
- Not required on record
- 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 March 2012
- Identifiers
- RxCUI 1234236, 1234238, 1234239 +3DailyMed set ID e8b8ec8d-1318-43e4-a182-446e9f9579deNDC 52244-040Application NDA020649
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
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
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 Edex 40 mcg/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.