NDC 0009-3701 Caverject

Alprostadil Injection, Powder, Lyophilized, For Solution Intracavernous - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0009-3701
Proprietary Name:
Caverject
Non-Proprietary Name: [1]
Alprostadil
Substance Name: [2]
Alprostadil
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Administration Route(s): [4]
  • Intracavernous - Administration within a pathologic cavity, such as occurs in the lung in tuberculosis.
  • Labeler Name: [5]
    Pharmacia & Upjohn Company Llc
    Labeler Code:
    0009
    FDA Application Number: [6]
    NDA020379
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    07-06-1995
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 0009-3701-05

    Package Description: 6 VIAL, SINGLE-DOSE in 1 PACKAGE / 1 mL in 1 VIAL, SINGLE-DOSE (0009-3701-08)

    Price per Unit: $95.71509 per EA

    Product Details

    What is NDC 0009-3701?

    The NDC code 0009-3701 is assigned by the FDA to the product Caverject which is a human prescription drug product labeled by Pharmacia & Upjohn Company Llc. The generic name of Caverject is alprostadil. The product's dosage form is injection, powder, lyophilized, for solution and is administered via intracavernous form. The product is distributed in a single package with assigned NDC code 0009-3701-05 6 vial, single-dose in 1 package / 1 ml in 1 vial, single-dose (0009-3701-08). This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Caverject?

    This medication is used to treat male sexual function problems (erectile dysfunction). It works by helping the blood flow into the penis to achieve and maintain an erection. This medication is not for use in women or children. This medication is not recommended for use in men with penile implants.

    What are Caverject Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    Which are Caverject UNII Codes?

    The UNII codes for the active ingredients in this product are:

    Which are Caverject Inactive Ingredients UNII Codes?

    The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

    What is the NDC to RxNorm Crosswalk for Caverject?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

    Which are the Pharmacologic Classes for Caverject?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    Patient Education

    Alprostadil Urogenital


    Alprostadil injection and suppositories are used to treat certain types of erectile dysfunction (impotence; inability to get or keep an erection) in men. Alprostadil injection is also sometimes used in combination with other tests to diagnose erectile dysfunction. Alprostadil is in a class of medications called vasodilators. It works by relaxing the muscles and blood vessels in the penis to keep enough blood in the penis so that an erection can occur. Alprostadil does not cure erectile dysfunction or increase sexual desire. Alprostadil does not prevent pregnancy or the spread of sexually transmitted diseases such as human immunodeficiency virus (HIV).
    [Learn More]


    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

    [8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

    [12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".