Silodosin Powder
NDC Package 42765-005-01

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 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.

Silodosin powders is silodosin is used by men to treat the symptoms of an enlarged prostate (benign prostatic hyperplasia-BPH). This formulation utilizes a powder delivery system. Marketed by Metrochem Api Private Limited, this product is identified by NDC 42765-005.

Identification & Billing

NDC Package Code
42765-005-01
Package Description
1 kg in 1 DRUM
Product Code
42765-005
11-Digit Billing Format
42765000501

Clinical Specifications

Proprietary Name
Silodosin
Non-Proprietary Name
Silodosin
Substance Name
Silodosin
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)
SILODOSIN 15 kg/15kg
Usage Information
Silodosin is used by men to treat the symptoms of an enlarged prostate (benign prostatic hyperplasia-BPH). It does not shrink the prostate, but it works by relaxing the muscles in the prostate and the bladder. This helps to relieve symptoms of BPH such as difficulty in beginning the flow of urine, weak stream, and the need to urinate often or urgently (including during the middle of the night). Silodosin belongs to a class of drugs known as alpha blockers. Do not use this medication to treat high blood pressure.

Regulatory & Marketing

Labeler Name
Metrochem Api Private Limited
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
01-17-2020
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (42765-005). Click a package code to view its specific billing and regulatory data.

42765-005-15
15 kg in 1 DRUM

* 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 42765-005-01 identifies a specific commercial package of 1 kg in 1 drum of Silodosin (UNFINISHED drug), a bulk ingredient labeled by Metrochem Api Private Limited. This powder is formulated for use and contains silodosin 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 Metrochem Api Private Limited on January 17, 2020. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Silodosin is used by men to treat the symptoms of an enlarged prostate (benign prostatic hyperplasia-BPH). It does not shrink the prostate, but it works by relaxing the muscles in the prostate and the bladder. This helps to relieve symptoms of BPH such as difficulty in beginning the flow of urine, weak stream, and the need to urinate often or urgently (including during the middle of the night). Silodosin belongs to a class of drugs known as alpha blockers. Do not use this medication to treat high blood pressure.

How is this Metrochem Api Private Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42765000501. 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)
42765-005-01
11-Digit CMS (5-4-2)
42765-0005-01

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