Silodosin Capsule
NDC Package 33342-385-12

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

Silodosin capsules is silodosin is used by men to treat the symptoms of an enlarged prostate (benign prostatic hyperplasia-BPH). This formulation utilizes a capsule delivery system. Marketed by Macleods Pharmaceuticals Limited, this product is identified by NDC 33342-385 and is authorized under FDA application ANDA211166.

Identification & Billing

NDC Package Code
33342-385-12
Package Description
100 BLISTER PACK in 1 CARTON / 10 CAPSULE in 1 BLISTER PACK
Product Code
33342-385
11-Digit Billing Format
33342038512
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Silodosin
Non-Proprietary Name
Silodosin
Substance Name
Silodosin
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.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
SILODOSIN 8 mg/1
Pharmacologic Class
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
Macleods Pharmaceuticals Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA211166
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-03-2018
Listing Expiration
12-31-2026
Exclude Flag
N
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 (33342-385). Click a package code to view its specific billing and regulatory data.

33342-385-07
30 CAPSULE in 1 BOTTLE
33342-385-10
90 CAPSULE 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 33342-385-12 identifies a specific commercial package of 100 blister pack in 1 carton / 10 capsule in 1 blister pack of Silodosin, a human prescription drug labeled by Macleods Pharmaceuticals Limited. This capsule is formulated for oral 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 Macleods Pharmaceuticals Limited on December 03, 2018. 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 Macleods Pharmaceuticals Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 33342038512. 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)
33342-385-12
11-Digit CMS (5-4-2)
33342-0385-12

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