Silodosin
NDC Package 68382-489-01

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 EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Silodosin is used by men to treat the symptoms of an enlarged prostate (benign prostatic hyperplasia-BPH). Marketed by Zydus Pharmaceuticals Usa Inc., this product is identified by NDC 68382-489 and is authorized under FDA application ANDA204816.

Identification & Billing

NDC Package Code
68382-489-01
Package Description
100 CAPSULE in 1 BOTTLE
Product Code
68382-489
11-Digit Billing Format
68382048901

Clinical Specifications

Proprietary Name
Silodosin
Dosage Form
-
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
Zydus Pharmaceuticals Usa Inc.
FDA Application #
ANDA204816
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-14-2025
End Marketing Date
05-13-2025
Listing Expiration
05-13-2025
Exclude Flag
D
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 (68382-489). Click a package code to view its specific billing and regulatory data.

68382-489-05
500 CAPSULE in 1 BOTTLE
68382-489-06
30 CAPSULE in 1 BOTTLE
68382-489-10
1000 CAPSULE in 1 BOTTLE
68382-489-16
90 CAPSULE in 1 BOTTLE
68382-489-77
10 BLISTER PACK in 1 CARTON / 10 CAPSULE in 1 BLISTER PACK (68382-489-30)

* 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 68382-489-01 identifies a specific commercial package of 100 capsule in 1 bottle of Silodosin, labeled by Zydus Pharmaceuticals Usa 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 Zydus Pharmaceuticals Usa Inc. on February 14, 2025. The current certification is valid through May 13, 2025.

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 Zydus Pharmaceuticals Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68382048901. 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)
68382-489-01
11-Digit CMS (5-4-2)
68382-0489-01

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