Edex

alprostadil · ALPROSTADIL 40 ug/mL · Injection, Powder, Lyophilized, For Solution · Intracavernous · Endo USA, Inc.

NDC 52244-0040-02 · 2 BLISTER PACK in 1 CARTON / 1 CARTRIDGE in 1 BLISTER PACK / 1 mL in 1 CARTRIDGE · NDA · View full market →

The short version

Just 2 companies supply this market — thin enough that a single exit would be felt immediately. Historically, drugs in this position went on to a new shortage within 90 days about 0.4% of the time — roughly 3× the typical drug (0.1%).

The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.

Medicare Part D

No Medicare Part D plan in CMS's quarterly files lists this product. That usually means it is discontinued, a repackager's listing, or a product no plan has added to its formulary.

How Part D pricing works →

NADAC price per unit

No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.

Estimated fill cost

WAC per package, as filed

$318.87

Reported to Texas DSHS · 2025 annual filing · Endo USA, Inc.

Manufacturer list price as filed — not what pharmacies actually pay after discounts.

Supply fragility

Not scored — fragility is computed for NADAC-priced NDCs.

90-day shortage risk (model v2)

0.4%chance of a new FDA shortage posting for alprostadil (injectable) in the next 90 days

sterile injectable · sole-source market · price up 5% YoY

For scale: the typical drug’s chance is about 0.1% — this one is 3× that.

Backtested statistical model over the whole market, not this package alone. Model details →

Is this a "specialty" drug?

There's no legal definition — it meets 1 of 6 public criteria. Why that matters →

Part D specialty tier
Costs ≥ $950/fill
Biologic (BLA)
Injectable / infused
Orphan-drug exclusivity
REMS program

Regulatory

Application: NDA020649
TE code: AP
Approval date: Jun 12, 1997
Patents / exclusivity: None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

Class II · TerminatedFeb 22, 2017
Endo Pharmaceuticals, Inc. — Lack of Assurance of Sterility: Defective container resulting in the lack of sterility assurance. ok thanks

Manufacturers of alprostadil (Injection, Powder, Lyophilized, For Solution)

Labeler	Strength	First seen	Last seen
Endo USA, Inc.	ALPROSTADIL 20 ug/mL	Jul 15, 2026	Sep 2, 2026
Endo USA, Inc.	ALPROSTADIL 10 ug/mL	Jul 15, 2026	Sep 2, 2026
Endo USA, Inc.	ALPROSTADIL 40 ug/mL	Jul 15, 2026	Sep 2, 2026
Pharmacia & Upjohn Company LLC	ALPROSTADIL 10 ug/.5mL	Jul 15, 2026	Sep 2, 2026
Pharmacia & Upjohn Company LLC	ALPROSTADIL 20.5 ug/mL	Jul 15, 2026	Sep 2, 2026
Pharmacia & Upjohn Company LLC	ALPROSTADIL 41.1 ug/mL	Jul 15, 2026	Sep 2, 2026
Pharmacia & Upjohn Company LLC	ALPROSTADIL 20 ug/.5mL	Jul 15, 2026	Sep 2, 2026

Roster from daily NDC Directory diffs — first/last seen dates start July 2026.

Cite this page

DrugDashboards, "Edex — NDC 52244-0040-02," retrieved September 3, 2026, https://drugdashboards.com/drug/52244004002.

Free to cite with attribution — see how the data is put together.