Edex (alprostadil) NDC 52244-010

NDC codes

FDA NDC Directory

Product NDC (as listed)52244-010Labeler and product segments. Claims need a package NDC.

Product NDC at billing width52244-0010Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
52244-010-02	52244001002	2 BLISTER PACK in 1 CARTON (52244-010-02) / 1 CARTRIDGE in 1 BLISTER PACK / 1 mL in 1 CARTRIDGEMarketed from Apr 15, 2012
52244-010-06	52244001006	6 BLISTER PACK in 1 CARTON (52244-010-06) / 1 CARTRIDGE in 1 BLISTER PACK / 1 mL in 1 CARTRIDGEMarketed from Apr 15, 2012

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Edex
Generic name (nonproprietary): alprostadil
Active ingredients: Alprostadil — 10 ug/mL
Dosage form: Injection, Powder, Lyophilized, For solution
Route: Intracavernous
Labeler: Endo USA, Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 020649
Marketing start: Apr 15, 2012
Listing expires: Dec 31, 2027
Other FDA classes: Genitourinary Arterial Vasodilation (Physiologic effect)Prostaglandin Receptor Agonists (Mechanism)Prostaglandins (Chemical structure)Venous Vasodilation (Physiologic effect)
Identifiers: Product ID 52244-010_160196d5-a339-455d-8b68-4c9f437929a5SPL ID 160196d5-a339-455d-8b68-4c9f437929a5SPL set ID e8b8ec8d-1318-43e4-a182-446e9f9579deRxCUI 1234236, 1234238, 1234239, 1234240, 1234241, 1234242UNII F5TD010360
Pharmacologic class: Prostaglandin Analog; Prostaglandin E1 Agonist

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N452244001002 followed by a unit qualifier and the quantity

Package 52244-0010-02. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Mar 27, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE edex ® is indicated for the treatment of erectile dysfunction due to neurogenic, vasculogenic, psychogenic, or mixed etiology.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 020649

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 020649
Product	Strength	Form · route	Labeler	Product NDC
Edexalprostadil	Alprostadil 20 ug/mL	Injection, Powder, Lyophilized, For solutionIntracavernous	Endo USA, Inc.	52244-020
Edexalprostadil	Alprostadil 40 ug/mL	Injection, Powder, Lyophilized, For solutionIntracavernous	Endo USA, Inc.	52244-040