Avodart
NDC Package 69784-712-04

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.

Avodart is a medication used in men to treat the symptoms of an enlarged prostate (benign prostatic hyperplasia-BPH). Marketed by Woodward Pharma Services Llc, this product is identified by NDC 69784-712 and is authorized under FDA application NDA021319.

Identification & Billing

NDC Package Code
69784-712-04
Package Description
90 CAPSULE, LIQUID FILLED in 1 BOTTLE
Product Code
69784-712
11-Digit Billing Format
69784071204
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
90 EA

Clinical Specifications

Proprietary Name
Avodart
Dosage Form
-
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
Woodward Pharma Services Llc
FDA Application #
NDA021319
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-15-2022
End Marketing Date
03-31-2025
Listing Expiration
03-31-2025
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 (69784-712). Click a package code to view its specific billing and regulatory data.

69784-712-15
30 CAPSULE, LIQUID FILLED 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 69784-712-04 identifies a specific commercial package of 90 capsule, liquid filled in 1 bottle of Avodart, labeled by Woodward Pharma Services Llc. 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 Woodward Pharma Services Llc on December 15, 2022. The current certification is valid through March 31, 2025.

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 Woodward Pharma Services Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69784071204. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 90 total billable units per package. 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)
69784-712-04
11-Digit CMS (5-4-2)
69784-0712-04

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