Danazol Capsule
NDC Package 62135-477-60

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Danazol capsules 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). This formulation utilizes a capsule delivery system. Marketed by Chartwell Rx, Llc., this product is identified by NDC 62135-477 and is authorized under FDA application ANDA077246.

Identification & Billing

NDC Package Code
62135-477-60
Package Description
60 CAPSULE in 1 BOTTLE
Product Code
62135-477
11-Digit Billing Format
62135047760
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Danazol
Non-Proprietary Name
Danazol
Substance Name
Danazol
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)
DANAZOL 200 mg/1
Pharmacologic Class
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
Chartwell Rx, Llc.
Product Type
Human Prescription Drug
FDA Application #
ANDA077246
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-28-2005
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 62135-477-60 identifies a specific commercial package of 60 capsule in 1 bottle of Danazol, a human prescription drug labeled by Chartwell Rx, Llc.. This capsule is formulated for oral use and contains danazol 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 Chartwell Rx, Llc. on September 28, 2005. The current certification is valid through December 31, 2026.

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 Chartwell Rx, Llc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 62135047760. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 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)
62135-477-60
11-Digit CMS (5-4-2)
62135-0477-60

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