Caverject Impulse
These highlights do not include all the information needed to use CAVERJECT IMPULSE safely and effectively. See full prescribing information for CAVERJECT IMPULSE. CAVERJECT IMPULSE (alprostadil) for injection, for intracavernosal use Initial U.S. Approval: 1981
Approved
Approval ID
d8f85a7e-becb-4e15-9829-40e8f359140a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 21, 2017
Manufacturers
FDA
U.S. Pharmaceuticals
DUNS: 829076905
Products 2
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 Code63539-121
Application NumberNDA021212
Product Classification
M
Marketing Category
C73594
G
Generic Name
Alprostadil
Product Specifications
Route of AdministrationINTRACAVERNOUS
Effective DateOctober 1, 2016
FDA Product Classification
INGREDIENTS (8)
ALPROSTADILActive
Quantity: 10 ug in 0.5 mL
Code: F5TD010360
Classification: ACTIB
ALFADEXInactive
Quantity: 324.7 ug in 0.5 mL
Code: Z1LH97KTRM
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Quantity: 23.5 ug in 0.5 mL
Code: 1Q73Q2JULR
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Quantity: 45.4 mg in 0.5 mL
Code: J2B2A4N98G
Classification: IACT
BENZYL ALCOHOLInactive
Quantity: 4.45 mg in 0.5 mL
Code: LKG8494WBH
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Alprostadil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63539-221
Application NumberNDA021212
Product Classification
M
Marketing Category
C73594
G
Generic Name
Alprostadil
Product Specifications
Route of AdministrationINTRACAVERNOUS
Effective DateOctober 1, 2016
FDA Product Classification
INGREDIENTS (8)
ALPROSTADILActive
Quantity: 20 ug in 0.5 mL
Code: F5TD010360
Classification: ACTIB
ALFADEXInactive
Quantity: 649.3 ug in 0.5 mL
Code: Z1LH97KTRM
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Quantity: 45.4 mg in 0.5 mL
Code: J2B2A4N98G
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Quantity: 23.5 ug in 0.5 mL
Code: 1Q73Q2JULR
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
BENZYL ALCOHOLInactive
Quantity: 4.45 mg in 0.5 mL
Code: LKG8494WBH
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT