Dutasteride Powder
NDC Package 59057-005-00

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. 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.

Dutasteride powders is a medication used in men to treat the symptoms of an enlarged prostate (benign prostatic hyperplasia-BPH). This formulation utilizes a powder delivery system. Marketed by Sterling Chemical Malta Ltd, this product is identified by NDC 59057-005.

Identification & Billing

NDC Package Code
59057-005-00
Package Description
20 kg in 1 BOX
Product Code
59057-005
11-Digit Billing Format
59057000500

Clinical Specifications

Proprietary Name
Dutasteride
Non-Proprietary Name
Dutasteride
Substance Name
Dutasteride
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
DUTASTERIDE 1 kg/kg
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
Sterling Chemical Malta Ltd
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
04-10-2015
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 59057-005-00 identifies a specific commercial package of 20 kg in 1 box of Dutasteride (UNFINISHED drug), a bulk ingredient labeled by Sterling Chemical Malta Ltd. This powder is formulated for use and contains dutasteride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Sterling Chemical Malta Ltd on April 10, 2015. The current certification is valid through December 31, 2026.

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 Sterling Chemical Malta Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59057000500. 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 (5-3-2)
59057-005-00
11-Digit CMS (5-4-2)
59057-0005-00

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