Quick answers
- What is Alprostadil used for?
- The FDA-approved label (Prostin Vr Pediatric, Pharmacia & Upjohn Company LLC, August 17, 2026) says: “PROSTIN VR PEDIATRIC Sterile Solution is 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 who have congenital heart defects and who depend upon the patent ductus for survival. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Alprostadil have a boxed warning?
- Yes. The FDA label for Prostin Vr Pediatric has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Alprostadil?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Alprostadil been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started February 22, 2017 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Alprostadil?
- 3 companies list prescription products of Alprostadil in the FDA NDC Directory, including Pharmacia & Upjohn Company LLC, Endo USA, Inc. and Meitheal Pharmaceuticals Inc..
What Alprostadil is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
PROSTIN VR PEDIATRIC Sterile Solution is 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 who have congenital heart defects and who depend upon the patent ductus for survival. …
— FDA label: Prostin Vr Pediatric, Pharmacia & Upjohn Company LLC, effective August 17, 2026. Read the full label on DailyMed →
The FDA has 6 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
3 of 6 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, powder, lyophilized, for solution · Injection, solution · Injection, solution, concentrate |
|---|---|
| Route | Intracavernous · Intravascular · Intravenous |
| Prescription products | 10 in the FDA NDC Directory |
| Brand names | Edex, Prostin Vr Pediatric, Caverject Impulse, Caverject |
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/0.5 mL injection, powder, lyophilized, for solution | Brand: Caverject Impulse | $82.49 per unit |
| alprostadil 10 ug/mL injection, powder, lyophilized, for solution | Brand: Edex | $182.92 per unit |
| alprostadil 20 ug/0.5 mL injection, powder, lyophilized, for solution | Brand: Caverject Impulse | $106.27 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 January 1, 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 this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Pharmacia & Upjohn Company LLC6 products
- Endo USA, Inc.3 products
- Meitheal Pharmaceuticals Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA018484 PROSTIN VR PEDIATRIC | Pfizer | October 16, 1981 | 19, latest December 22, 2025 2025: Labeling · 2019: Labeling · 2014: Manufacturing (CMC) |
| NDA020379 CAVERJECT | Pfizer | July 6, 1995 | 26, latest December 23, 2022 2022: Labeling · 2017: Labeling · 2017: Labeling |
| NDA020649 EDEX | Endo Operations | June 12, 1997 | 18, latest November 17, 2016 2016: Manufacturing (CMC) · 2015: Labeling · 2014: Manufacturing (CMC) |
| NDA021212 CAVERJECT IMPULSE | Pfizer | June 11, 2002 | 10, latest December 23, 2022 2022: Labeling · 2016: Manufacturing (CMC) · 2016: Labeling |
Generic approvals (1)
- ANDA075196Meitheal · April 30, 1999
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: 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.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Prostin Vr Pediatric, Pharmacia & Upjohn Company LLC, effective August 17, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- 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 recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →