Caverject Impulse

Basic Information

Product Name

Caverject Impulse

FDA Product Code

0009-5182

Regulatory Information

NDC Product Code

0009-5182

Application Number

NDA021212

Marketing Category

C73594

Effective Date

December 23, 2022

Territorial Authority

USA

FDA Title

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 useInitial U.S. Approval: 1981

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

ALPROSTADIL

Quantity: 20 ug in 0.5 mL

Code: F5TD010360

Class Code: ACTIB

ALFADEX

Quantity: 649.3 ug in 0.5 mL

Code: Z1LH97KTRM

Class Code: IACT

SODIUM HYDROXIDE

Code: 55X04QC32I

Class Code: IACT

SODIUM CITRATE, UNSPECIFIED FORM

Quantity: 23.5 ug in 0.5 mL

Code: 1Q73Q2JULR

Class Code: IACT

HYDROCHLORIC ACID

Code: QTT17582CB

Class Code: IACT

BENZYL ALCOHOL

Quantity: 4.45 mg in 0.5 mL

Code: LKG8494WBH

Class Code: IACT

LACTOSE, UNSPECIFIED FORM

Quantity: 45.4 mg in 0.5 mL

Code: J2B2A4N98G

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

Active Moieties

ALPROSTADIL

Code: F5TD010360

Basic Information

Regulatory Information

Company Information

Active Ingredients

ALFADEX

SODIUM HYDROXIDE

SODIUM CITRATE, UNSPECIFIED FORM

HYDROCHLORIC ACID

BENZYL ALCOHOL

LACTOSE, UNSPECIFIED FORM

WATER

Active Moieties

ALPROSTADIL