Griseofulvin
NDC Package 59366-2900-4

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 discontinued by the firm.

Griseofulvin is a medication used to treat fungal infections of the skin, hair, and nails that do not respond to creams/lotions. Marketed by Glades Pharmaceuticals, Llc, this product is identified by NDC 59366-2900 and is authorized under FDA application ANDA065200.

Identification & Billing

NDC Package Code
59366-2900-4
Package Description
120 mL in 1 BOTTLE
Product Code
59366-2900
11-Digit Billing Format
59366290004

Clinical Specifications

Proprietary Name
Griseofulvin
Dosage Form
-
Usage Information
This medication is used to treat fungal infections of the skin, hair, and nails that do not respond to creams/lotions. Clearing such infections will get rid of symptoms such as itching, red/peeling/scaly skin, and discolored nails. This medication works by stopping the growth of fungi. It does not treat infections due to bacteria or yeast.

Regulatory & Marketing

Labeler Name
Glades Pharmaceuticals, Llc
FDA Application #
ANDA065200
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-31-2009
End Marketing Date
01-01-2010
Listing Expiration
01-01-2010
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 59366-2900-4 identifies a specific commercial package of 120 ml in 1 bottle of Griseofulvin, labeled by Glades Pharmaceuticals, 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 Glades Pharmaceuticals, Llc on December 31, 2009. The current certification is valid through January 01, 2010.

What are the primary indications for this medication?

This medication is used to treat fungal infections of the skin, hair, and nails that do not respond to creams/lotions. Clearing such infections will get rid of symptoms such as itching, red/peeling/scaly skin, and discolored nails. This medication works by stopping the growth of fungi. It does not treat infections due to bacteria or yeast.

How is this Glades Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59366290004. 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)
59366-2900-4
11-Digit CMS (5-4-2)
59366-2900-04

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