Finasteride
NDC Package 50436-0446-3

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.

Finasteride is used to shrink an enlarged prostate (benign prostatic hyperplasia or BPH) in adult men. Marketed by Unit Dose Services, this product is identified by NDC 50436-0446 and is authorized under FDA application ANDA090507.

Identification & Billing

NDC Package Code
50436-0446-3
Package Description
90 TABLET, FILM COATED in 1 BOTTLE
Product Code
50436-0446
11-Digit Billing Format
50436044603

Clinical Specifications

Proprietary Name
Finasteride
Dosage Form
-
Usage Information
Finasteride is used to shrink an enlarged prostate (benign prostatic hyperplasia or BPH) in adult men. It may be used alone or taken in combination with other medications to reduce symptoms of BPH and may also reduce the need for surgery. Finasteride may improve symptoms of BPH and provide benefits such as decreased urge to urinate, better urine flow with less straining, less of a feeling that the bladder is not completely emptied, and decreased nighttime urination. This medication works by decreasing the amount of a natural body hormone (DHT) that causes growth of the prostate. Finasteride 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. Women and children should not use this medication.

Regulatory & Marketing

Labeler Name
Unit Dose Services
FDA Application #
ANDA090507
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-18-2011
End Marketing Date
12-31-2017
Listing Expiration
12-31-2017
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 (50436-0446). Click a package code to view its specific billing and regulatory data.

50436-0446-1
30 TABLET, FILM COATED 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 50436-0446-3 identifies a specific commercial package of 90 tablet, film coated in 1 bottle of Finasteride, labeled by Unit Dose Services. 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 Unit Dose Services on August 18, 2011. The current certification is valid through December 31, 2017.

What are the primary indications for this medication?

Finasteride is used to shrink an enlarged prostate (benign prostatic hyperplasia or BPH) in adult men. It may be used alone or taken in combination with other medications to reduce symptoms of BPH and may also reduce the need for surgery. Finasteride may improve symptoms of BPH and provide benefits such as decreased urge to urinate, better urine flow with less straining, less of a feeling that the bladder is not completely emptied, and decreased nighttime urination. This medication works by decreasing the amount of a natural body hormone (DHT) that causes growth of the prostate. Finasteride 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. Women and children should not use this medication.

How is this Unit Dose Services product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50436044603. 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)
50436-0446-3
11-Digit CMS (5-4-2)
50436-0446-03

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