Dutasteride
NDC Package 62112-8068-2

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Dutasteride is a medication used in men to treat the symptoms of an enlarged prostate (benign prostatic hyperplasia-BPH). Marketed by Intergel Pharmaceuticals Inc, this product is identified by NDC 62112-8068 and is authorized under FDA application ANDA206373.

Identification & Billing

NDC Package Code
62112-8068-2
Package Description
90 CAPSULE, LIQUID FILLED in 1 BOTTLE
Product Code
62112-8068
11-Digit Billing Format
62112806802
RxNorm Crosswalk
RxCUI: 351172 - dutasteride 0.5 MG Oral Capsule

Clinical Specifications

Proprietary Name
Dutasteride
Dosage Form
-
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.

Regulatory & Marketing

Labeler Name
Intergel Pharmaceuticals Inc
FDA Application #
ANDA206373
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-10-2002
Listing Expiration
12-31-2021
Exclude Flag
I
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (62112-8068). Click a package code to view its specific billing and regulatory data.

62112-8068-1
30 CAPSULE, LIQUID FILLED in 1 BOTTLE

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 62112-8068-2 identifies a specific commercial package of 90 capsule, liquid filled in 1 bottle of Dutasteride, labeled by Intergel Pharmaceuticals Inc. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Intergel Pharmaceuticals Inc on December 10, 2002. The current certification is valid through December 31, 2021.

What are the primary indications for this medication?

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.

How is this Intergel Pharmaceuticals Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 62112806802. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-4-1)
62112-8068-2
11-Digit CMS (5-4-2)
62112-8068-02

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.