Cabergoline
NDC Package 83085-003-08

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Cabergoline is a medication used to treat high levels of prolactin hormone in your body. Marketed by Skg Pharma Inc., this product is identified by NDC 83085-003 and is authorized under FDA application ANDA218618.

Identification & Billing

NDC Package Code
83085-003-08
Package Description
8 TABLET in 1 BOTTLE
Product Code
83085-003
11-Digit Billing Format
83085000308
RxNorm Crosswalk
RxCUI: 199703 - cabergoline 0.5 MG Oral Tablet

Clinical Specifications

Proprietary Name
Cabergoline
Dosage Form
-
Usage Information
This medication is used to treat high levels of prolactin hormone in your body. High levels of prolactin in women can cause symptoms such as unwanted breast milk and missed periods and can cause difficulty becoming pregnant. High levels of prolactin in men can cause symptoms such as enlarged breasts and decreased sexual ability/desire. Cabergoline is an ergot medication and works by blocking the release of prolactin from the pituitary gland.

Regulatory & Marketing

Labeler Name
Skg Pharma Inc.
FDA Application #
ANDA218618
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-05-2024
Listing Expiration
12-31-2025
Exclude Flag
I
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 83085-003-08 identifies a specific commercial package of 8 tablet in 1 bottle of Cabergoline, labeled by Skg Pharma Inc.. 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 Skg Pharma Inc. on July 05, 2024. The current certification is valid through December 31, 2025.

What are the primary indications for this medication?

This medication is used to treat high levels of prolactin hormone in your body. High levels of prolactin in women can cause symptoms such as unwanted breast milk and missed periods and can cause difficulty becoming pregnant. High levels of prolactin in men can cause symptoms such as enlarged breasts and decreased sexual ability/desire. Cabergoline is an ergot medication and works by blocking the release of prolactin from the pituitary gland.

How is this Skg Pharma Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83085000308. 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)
83085-003-08
11-Digit CMS (5-4-2)
83085-0003-08

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