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  5. NDC Package Code: 11014-0215-3 Dutasteride

NDC Package 11014-0215-3 Dutasteride

Capsule - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
11014-0215-3
Package Description:
1 BAG in 1 CARTON / 20000 CAPSULE in 1 BAG
Product Code:
11014-0215
Non-Proprietary Name:
Dutasteride
Substance Name:
Dutasteride
Usage Information:
This medication is used in men to treat the symptoms of an enlarged prostate (benign prostatic hyperplasia-BPH). It works by reducing the size of the enlarged prostate. This helps to relieve symptoms of BPH such as difficulty in beginning the flow of urine, weak stream, and the need to urinate frequently or urgently (including during the middle of the night). It may also reduce the need for surgery to treat BPH. Dutasteride is not approved for prevention of prostate cancer. It may slightly increase the risk of developing a very serious form of prostate cancer. Talk to your doctor about the benefits and risks. This medication should not be used by women or children.
11-Digit NDC Billing Format:
11014021503
Product Type:
Drug For Further Processing
Labeler Name:
Catalent Pharma Solutions, Llc
Dosage Form:
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Active Ingredient(s):
  • DUTASTERIDE .5 mg/1
    • Sample Package:
    N/A
    Marketing Category:
    EXPORT ONLY - A product that is only exported and not marketed in the United States.
    Start Marketing Date:
    12-19-2015
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Unfinished Product:
    Yes
    Code Structure:

    The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

    * Please review the disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    11014-0215-11 BAG in 1 CONTAINER / 14000 CAPSULE in 1 BAG
    11014-0215-21 BAG in 1 CONTAINER / 10000 CAPSULE in 1 BAG

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 11014-0215-3?

    The NDC Packaged Code 11014-0215-3 is assigned to an UNFINISHED drug package of 1 bag in 1 carton / 20000 capsule in 1 bag of Dutasteride, drug for further processing labeled by Catalent Pharma Solutions, Llc. The product's dosage form is capsule and is administered via form.

    Is NDC 11014-0215 included in the NDC Directory?

    Yes, Dutasteride is an UNFINISHED PRODUCT with code 11014-0215 that is active and included in the NDC Directory. The product was first marketed by Catalent Pharma Solutions, Llc on December 19, 2015 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 11014-0215-3?

    The 11-digit format is 11014021503. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-4-1 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-4-111014-0215-35-4-211014-0215-03