Danazol
NDC Package 42291-243-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

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

Danazol is a medication used in women to treat pelvic pain and infertility due to a certain uterus disorder (endometriosis) and also to treat breast pain/tenderness/nodules due to a certain breast condition (fibrocystic breast disease). Marketed by Avkare, this product is identified by NDC 42291-243 and is authorized under FDA application ANDA074582.

Identification & Billing

NDC Package Code
42291-243-01
Package Description
100 CAPSULE in 1 BOTTLE
Product Code
11-Digit Billing Format
42291024301
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA

Clinical Specifications

Proprietary Name
Danazol
Dosage Form
-
Usage Information
This medication is used in women to treat pelvic pain and infertility due to a certain uterus disorder (endometriosis) and also to treat breast pain/tenderness/nodules due to a certain breast condition (fibrocystic breast disease). It is also used in both men and women to prevent swelling of the abdomen/arms/legs/face/airway due to a certain congenital disease (hereditary angioedema). Danazol is an androgen similar to testosterone. For the treatment of endometriosis and fibrocystic breast disease, it works by decreasing the amount of hormones made by the ovaries. These hormones usually make the conditions worse. For the treatment of angioedema, danazol helps to increase the amount of a certain protein in your body's defense system (immune system).

Regulatory & Marketing

Labeler Name
Avkare
FDA Application #
ANDA074582
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-23-2016
End Marketing Date
04-30-2021
Listing Expiration
04-30-2021
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 42291-243-01 identifies a specific commercial package of 100 capsule in 1 bottle of Danazol, labeled by Avkare. This product is billed for "EA" each discreet unit and contains an estimated amount of 100 billable units per package. 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 Avkare on February 23, 2016. The current certification is valid through April 30, 2021.

What are the primary indications for this medication?

This medication is used in women to treat pelvic pain and infertility due to a certain uterus disorder (endometriosis) and also to treat breast pain/tenderness/nodules due to a certain breast condition (fibrocystic breast disease). It is also used in both men and women to prevent swelling of the abdomen/arms/legs/face/airway due to a certain congenital disease (hereditary angioedema). Danazol is an androgen similar to testosterone. For the treatment of endometriosis and fibrocystic breast disease, it works by decreasing the amount of hormones made by the ovaries. These hormones usually make the conditions worse. For the treatment of angioedema, danazol helps to increase the amount of a certain protein in your body's defense system (immune system).

How is this Avkare product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42291024301. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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)
42291-243-01
11-Digit CMS (5-4-2)
42291-0243-01

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