Quick answers
- What is Edex?
- Edex is a brand name of Alprostadil, a prescription medicine. The FDA NDC Directory lists 3 Edex products in 3 strengths and forms.
- Who makes Edex?
- Endo Operations holds the FDA application for Edex (NDA020649, approved June 12, 1997).
- Is there a generic or store brand of Edex?
- Other products of Alprostadil are listed with the FDA, but none in exactly the same strength and form as a Edex product.
- What do pharmacies pay for Edex?
- CMS lists a National Average Drug Acquisition Cost (NADAC) for 2 Edex strengths and forms (see the table below). That is what pharmacies pay to buy it, not what you pay: your price depends on your insurance and your pharmacy.
- Has Edex been recalled?
- FDA enforcement reports list 1 recall of Edex products; the newest started February 22, 2017. A recall usually concerns specific lots, not every product.
What Edex is
Each Edex product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Alprostadil · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| alprostadil 10 ug/mL injection, powder, lyophilized, for solution (intracavernous) | Edex | None listed | DailyMed |
| alprostadil 20 ug/mL injection, powder, lyophilized, for solution (intracavernous) | Edex | None listed | DailyMed |
| alprostadil 40 ug/mL injection, powder, lyophilized, for solution (intracavernous) | Edex | None listed | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Alprostadil →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA020649 | Endo Operations | June 12, 1997 | 3 |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| alprostadil 10 ug/mL injection, powder, lyophilized, for solution | Brand: Edex | $182.92 per unit |
| alprostadil 20 ug/mL injection, powder, lyophilized, for solution | Brand: Edex | $237.54 per unit |
NADAC list of November 4, 2026; these prices took effect between February 18, 2026 and October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list Edex
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Edex products.
- Endo USA, Inc.3 products
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
February 22, 2017 · Class II · Terminated · D-0512-2017
Lack of Assurance of Sterility: Defective container resulting in the lack of sterility assurance. ok thanks
Edex (alprostadil for injection) 10mcg, packaged in a 2 pack carton, Rx only, Manufactured in Germany for: Actient Pharmaceuticals, LLC, Lake Forest, Illinois 60045; NDC 52244-010-02. — Endo Pharmaceuticals, Inc.
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.