Edex
edex (alprostadil for injection)
Approved
Approval ID
e8b8ec8d-1318-43e4-a182-446e9f9579de
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 11, 2022
Manufacturers
FDA
Endo Pharmaceuticals Inc.
DUNS: 178074951
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
alprostadil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52244-040
Application NumberNDA020649
Product Classification
M
Marketing Category
C73594
G
Generic Name
alprostadil
Product Specifications
Route of AdministrationINTRACAVERNOUS
Effective DateJuly 11, 2022
FDA Product Classification
INGREDIENTS (5)
ALFADEXInactive
Code: Z1LH97KTRM
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
ALPROSTADILActive
Quantity: 40 ug in 1 mL
Code: F5TD010360
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
alprostadil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52244-010
Application NumberNDA020649
Product Classification
M
Marketing Category
C73594
G
Generic Name
alprostadil
Product Specifications
Route of AdministrationINTRACAVERNOUS
Effective DateJuly 11, 2022
FDA Product Classification
INGREDIENTS (5)
ALPROSTADILActive
Quantity: 10 ug in 1 mL
Code: F5TD010360
Classification: ACTIB
ALFADEXInactive
Code: Z1LH97KTRM
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
alprostadil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52244-020
Application NumberNDA020649
Product Classification
M
Marketing Category
C73594
G
Generic Name
alprostadil
Product Specifications
Route of AdministrationINTRACAVERNOUS
Effective DateJuly 11, 2022
FDA Product Classification
INGREDIENTS (5)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
ALFADEXInactive
Code: Z1LH97KTRM
Classification: IACT
ALPROSTADILActive
Quantity: 20 ug in 1 mL
Code: F5TD010360
Classification: ACTIB