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 ID52244-010_55623da4-8a70-42f5-9b88-c292595bbb89
NDC52244-010
Product TypeHuman Prescription Drug
Proprietary NameEdex
Generic NameAlprostadil
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRACAVERNOUS
Marketing Start Date2012-04-15
Marketing CategoryNDA / NDA
Application NumberNDA020649
Labeler NameEndo Pharmaceuticals, Inc.
Substance NameALPROSTADIL
Active Ingredient Strength10 ug/mL
Pharm ClassesGenitourinary Arterial Vasodilation [PE],Prostaglandin Analog [EPC],Prostaglandin E1 Agonist [EPC],Prostaglandin Receptor Agonists [MoA],Prostaglandins [CS],Venous Vasodilation [PE]
NDC Exclude FlagN
Listing Certified Through2020-12-31

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 Date2012-04-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52244-010-06 [52244001006]

Edex INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA020649
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-04-15

NDC 52244-010-02 [52244001002]

Edex INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA020649
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-04-15

Drug Details

Active Ingredients

IngredientStrength
ALPROSTADIL10 ug/mL

OpenFDA Data

SPL SET ID:e8b8ec8d-1318-43e4-a182-446e9f9579de
Manufacturer
UNII
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"

    NDCBrand NameGeneric Name
    52244-010Edexalprostadil
    52244-020Edexalprostadil
    52244-040Edexalprostadil
    0703-1501AlprostadilAlprostadil
    0009-3701CaverjectAlprostadil
    0009-7686CaverjectAlprostadil
    0009-5181Caverject ImpulseAlprostadil
    0009-5182Caverject ImpulseAlprostadil
    63539-121Caverject ImpulseAlprostadil
    63539-221Caverject ImpulseAlprostadil
    0037-8110MUSEAlprostadil
    0037-8120MUSEAlprostadil
    0037-8130MUSEAlprostadil
    0037-8140MUSEAlprostadil
    0009-0215PROSTINalprostadil
    0009-3169PROSTINalprostadil

    Trademark Results [Edex]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    EDEX
    EDEX
    79235696 not registered Live/Pending
    Edex - Educational Excellence Corporation Limited
    2018-01-08
    EDEX
    EDEX
    75089727 2177234 Live/Registered
    ACTIENT PHARMACEUTICALS LLC
    1996-04-17
    EDEX
    EDEX
    74150104 not registered Dead/Abandoned
    EDEX Group, The
    1991-03-22
    EDEX
    EDEX
    73680949 1523256 Dead/Cancelled
    DORON PRECISION SYSTEMS, INC.
    1987-08-27
    EDEX
    EDEX
    73648686 not registered Dead/Abandoned
    EDUCATIONAL EXPERIENCES, INC.
    1987-03-09
    EDEX
    EDEX
    72162150 0758090 Dead/Expired
    EDEX CORPORATION
    1963-02-06

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