NDC 52244-010

Edex

Alprostadil

Edex is a Intracavernous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Endo Pharmaceuticals, Inc.. The primary component is Alprostadil.

• Product ID: 52244-010_55623da4-8a70-42f5-9b88-c292595bbb89
• NDC: 52244-010
• Product Type: Human Prescription Drug
• Proprietary Name: Edex
• Generic Name: Alprostadil
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRACAVERNOUS
• Marketing Start Date: 2012-04-15
• Marketing Category: NDA / NDA
• Application Number: NDA020649
• Labeler Name: Endo Pharmaceuticals, Inc.
• Substance Name: ALPROSTADIL
• Active Ingredient Strength: 10 ug/mL
• Pharm Classes: Genitourinary Arterial Vasodilation [PE],Prostaglandin Analog [EPC],Prostaglandin E1 Agonist [EPC],Prostaglandin Receptor Agonists [MoA],Prostaglandins [CS],Venous Vasodilation [PE]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 52244-010-02

2 BLISTER PACK in 1 CARTON (52244-010-02) > 1 CARTRIDGE in 1 BLISTER PACK > 1 mL in 1 CARTRIDGE

• Marketing Start Date: 2012-04-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 52244-010-06 [52244001006]

Edex INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA020649
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-04-15

NDC 52244-010-02 [52244001002]

Edex INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA020649
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-04-15

Drug Details

Active Ingredients

Ingredient	Strength
ALPROSTADIL	10 ug/mL

OpenFDA Data

• SPL SET ID: e8b8ec8d-1318-43e4-a182-446e9f9579de
• Manufacturer:
  • Endo Pharmaceuticals, Inc.
• UNII:
  • F5TD010360
• RxNorm Concept Unique ID - RxCUI:
  • 1234238
  • 1234239
  • 1234236
  • 1234241
  • 1234240
  • 1234242
• Pharm Class PE:
  • Genitourinary Arterial Vasodilation [PE]
  • Venous Vasodilation [PE]
• PHarm Class EPC:
  • Prostaglandin Analog [EPC]
  • Prostaglandin E1 Agonist [EPC]
• NUI Code:
  • N0000009059
  • N0000000106
  • N0000175454
  • N0000007706
  • N0000009911
  • N0000180189

Pharmacological Class

• Genitourinary Arterial Vasodilation [PE]
• Prostaglandin Analog [EPC]
• Prostaglandin E1 Agonist [EPC]
• Prostaglandin Receptor Agonists [MoA]
• Prostaglandins [Chemical/Ingredient]
• Venous Vasodilation [PE]
• Prostaglandins [CS]
• Genitourinary Arterial Vasodilation [PE]
• Prostaglandin Analog [EPC]
• Prostaglandin E1 Agonist [EPC]
• Prostaglandin Receptor Agonists [MoA]
• Prostaglandins [CS]
• Venous Vasodilation [PE]

Medicade Reported Pricing

52244010010 THEO-24 ER 100 MG CAPSULE

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "Edex" or generic name "Alprostadil"

NDC	Brand Name	Generic Name
52244-010	Edex	alprostadil
52244-020	Edex	alprostadil
52244-040	Edex	alprostadil
0703-1501	Alprostadil	Alprostadil
0009-3701	Caverject	Alprostadil
0009-7686	Caverject	Alprostadil
0009-5181	Caverject Impulse	Alprostadil
0009-5182	Caverject Impulse	Alprostadil
63539-121	Caverject Impulse	Alprostadil
63539-221	Caverject Impulse	Alprostadil
0037-8110	MUSE	Alprostadil
0037-8120	MUSE	Alprostadil
0037-8130	MUSE	Alprostadil
0037-8140	MUSE	Alprostadil
0009-0215	PROSTIN	alprostadil
0009-3169	PROSTIN	alprostadil