edex

Generic: alprostadil

Labeler: endo usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name edex
Generic Name alprostadil
Labeler endo usa, inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRACAVERNOUS
Active Ingredients

alprostadil 20 ug/mL

Manufacturer
Endo USA, Inc.

Identifiers & Regulatory

Product NDC 52244-020
Product ID 52244-020_7c40fd8e-69c9-4f07-87e8-0ab6ebfe818e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020649
Listing Expiration 2027-12-31
Marketing Start 2012-01-15

Pharmacologic Class

Established (EPC)
prostaglandin analog [epc] prostaglandin e1 agonist [epc]
Mechanism of Action
prostaglandin receptor agonists [moa]
Chemical Structure
prostaglandins [cs]
Physiologic Effect
genitourinary arterial vasodilation [pe] venous vasodilation [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 52244020
Hyphenated Format 52244-020

Supplemental Identifiers

RxCUI
1234236 1234238 1234239 1234240 1234241 1234242
UNII
F5TD010360
NUI
N0000009059 N0000175454 N0000180189 N0000000106 M0017805 N0000009911

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name edex (source: ndc)
Generic Name alprostadil (source: ndc)
Application Number NDA020649 (source: ndc)
Routes
INTRACAVERNOUS
source: ndc

Resolved Composition

Strengths
  • 20 ug/mL
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (52244-020-02) / 1 CARTRIDGE in 1 BLISTER PACK / 1 mL in 1 CARTRIDGE
  • 6 BLISTER PACK in 1 CARTON (52244-020-06) / 1 CARTRIDGE in 1 BLISTER PACK / 1 mL in 1 CARTRIDGE
source: ndc

Packages (2)

52244-020-02 2 BLISTER PACK in 1 CARTON (52244-020-02) / 1 CARTRIDGE in 1 BLISTER PACK / 1 mL in 1 CARTRIDGE 52244-020-06 6 BLISTER PACK in 1 CARTON (52244-020-06) / 1 CARTRIDGE in 1 BLISTER PACK / 1 mL in 1 CARTRIDGE

Ingredients (1)

alprostadil (20 ug/mL)

Linked Drug Pages (1)

Edex ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRACAVERNOUS"], "spl_id": "7c40fd8e-69c9-4f07-87e8-0ab6ebfe818e", "openfda": {"nui": ["N0000009059", "N0000175454", "N0000180189", "N0000000106", "M0017805", "N0000009911"], "unii": ["F5TD010360"], "rxcui": ["1234236", "1234238", "1234239", "1234240", "1234241", "1234242"], "spl_set_id": ["e8b8ec8d-1318-43e4-a182-446e9f9579de"], "pharm_class_cs": ["Prostaglandins [CS]"], "pharm_class_pe": ["Genitourinary Arterial Vasodilation [PE]", "Venous Vasodilation [PE]"], "pharm_class_epc": ["Prostaglandin Analog [EPC]", "Prostaglandin E1 Agonist [EPC]"], "pharm_class_moa": ["Prostaglandin Receptor Agonists [MoA]"], "manufacturer_name": ["Endo USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (52244-020-02)  / 1 CARTRIDGE in 1 BLISTER PACK / 1 mL in 1 CARTRIDGE", "package_ndc": "52244-020-02", "marketing_start_date": "20120115"}, {"sample": false, "description": "6 BLISTER PACK in 1 CARTON (52244-020-06)  / 1 CARTRIDGE in 1 BLISTER PACK / 1 mL in 1 CARTRIDGE", "package_ndc": "52244-020-06", "marketing_start_date": "20120115"}], "brand_name": "Edex", "product_id": "52244-020_7c40fd8e-69c9-4f07-87e8-0ab6ebfe818e", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Genitourinary Arterial Vasodilation [PE]", "Prostaglandin Analog [EPC]", "Prostaglandin E1 Agonist [EPC]", "Prostaglandin Receptor Agonists [MoA]", "Prostaglandins [CS]", "Venous Vasodilation [PE]"], "product_ndc": "52244-020", "generic_name": "alprostadil", "labeler_name": "Endo USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Edex", "active_ingredients": [{"name": "ALPROSTADIL", "strength": "20 ug/mL"}], "application_number": "NDA020649", "marketing_category": "NDA", "marketing_start_date": "20120115", "listing_expiration_date": "20271231"}