Griseofulvin Suspension
NDC Package 0713-0850-04

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

Package Information

Griseofulvin suspension is a medication used to treat fungal infections of the skin, hair, and nails that do not respond to creams/lotions. This formulation utilizes a suspension delivery system. Marketed by Cosette Pharmaceuticals, Inc., this product is identified by NDC 0713-0850 and is authorized under FDA application ANDA065438.

Identification & Billing

NDC Package Code
0713-0850-04
Package Description
118 mL in 1 BOTTLE, PLASTIC
Product Code
0713-0850
11-Digit Billing Format
00713085004
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
118 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Griseofulvin
Non-Proprietary Name
Griseofulvin
Substance Name
Griseofulvin
Dosage Form
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
GRISEOFULVIN 125 mg/5mL
Pharmacologic Class
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
Cosette Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA065438
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-01-2022
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 0713-0850-04 identifies a specific commercial package of 118 ml in 1 bottle, plastic of Griseofulvin, a human prescription drug labeled by Cosette Pharmaceuticals, Inc.. This suspension is formulated for oral use and contains griseofulvin 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 Cosette Pharmaceuticals, Inc. on November 01, 2022. The current certification is valid through December 31, 2026.

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 Cosette Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00713085004. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 118 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 (4-4-2)
0713-0850-04
11-Digit CMS (5-4-2)
00713-0850-04

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