Griseofulvin
NDC Package 68682-520-01

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 Oceanside Pharmaceuticals, this product is identified by NDC 68682-520 and is authorized under FDA application NDA050475.

Identification & Billing

NDC Package Code
68682-520-01
Package Description
100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code
68682-520
11-Digit Billing Format
68682052001
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
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
Oceanside Pharmaceuticals
FDA Application #
NDA050475
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
07-26-2016
End Marketing Date
09-02-2019
Listing Expiration
09-02-2019
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 68682-520-01 identifies a specific commercial package of 100 tablet, film coated in 1 bottle, plastic of Griseofulvin, labeled by Oceanside Pharmaceuticals. 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 Oceanside Pharmaceuticals on July 26, 2016. The current certification is valid through September 02, 2019.

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 Oceanside Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68682052001. 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)
68682-520-01
11-Digit CMS (5-4-2)
68682-0520-01

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