Edex Injection, Powder, Lyophilized, For Solution
NDC Package 52244-040-06
Package Information
Edex (alprostadil) injection is a medication used to treat male sexual function problems (erectile dysfunction). This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Endo Usa, Inc., this product is identified by NDC 52244-040 and is authorized under FDA application NDA020649.
Identification & Billing
- RxCUI: 1234236 - alprostadil 10 MCG in 1 ML Cartridge
- RxCUI: 1234236 - 1 ML alprostadil 0.01 MG/ML Cartridge
- RxCUI: 1234236 - alprostadil 10 MCG per 1 ML Cartridge
- RxCUI: 1234238 - edex 10 MCG in 1 ML Cartridge
- RxCUI: 1234238 - 1 ML alprostadil 0.01 MG/ML Cartridge [Edex]
Clinical Specifications
- Genitourinary Arterial Vasodilation - [PE] (Physiologic Effect)
- Prostaglandin Analog - [EPC] (Established Pharmacologic Class)
- Prostaglandin E1 Agonist - [EPC] (Established Pharmacologic Class)
- Prostaglandin Receptor Agonists - [MoA] (Mechanism of Action)
- Prostaglandins - [CS]
- Venous Vasodilation - [PE] (Physiologic Effect)
Regulatory & Marketing
Hierarchy Structure
- 52244 - Endo Usa, Inc.
- 52244-040 - Edex
- 52244-040-06 - 6 BLISTER PACK in 1 CARTON / 1 CARTRIDGE in 1 BLISTER PACK / 1 mL in 1 CARTRIDGE (52244-040-01)
- 52244-040 - Edex
The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.
* Please review the full disclaimer at the bottom of this page.
Other Available Packages
The following commercial packages are registered under the same Product NDC (52244-040). Click a package code to view its specific billing and regulatory data.
* Please review the full disclaimer at the bottom of this page.
Frequently Asked Questions
What is the distribution configuration for this product package?
The code 52244-040-06 identifies a specific commercial package of 6 blister pack in 1 carton / 1 cartridge in 1 blister pack / 1 ml in 1 cartridge (52244-040-01) of Edex, a human prescription drug labeled by Endo Usa, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This injection, powder, lyophilized, for solution is formulated for intracavernous use and contains alprostadil as the active substance.
Is this product currently listed with the FDA?
Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Endo Usa, Inc. on March 15, 2012. The current certification is valid through December 31, 2027.
What are the primary indications for this medication?
This medication is used to treat male sexual function problems (erectile dysfunction). It works by helping the blood flow into the penis to achieve and maintain an erection. This medication is not for use in women or children. This medication is not recommended for use in men with penile implants.
How is this Endo Usa, Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 52244004006. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.
11-Digit Code Conversion
Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.
