Griseofulvin Tablet
NDC Package 42794-012-08

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

Package Information

Griseofulvin tablets 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 tablet delivery system. Marketed by Sigmapharm Laboratories, Llc, this product is identified by NDC 42794-012 and is authorized under FDA application ANDA202482.

Identification & Billing

NDC Package Code
42794-012-08
Package Description
30 TABLET in 1 BOTTLE
Product Code
42794-012
11-Digit Billing Format
42794001208
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk
RxCUI: 310600 - griseofulvin 500 MG Oral Tablet

Clinical Specifications

Proprietary Name
Griseofulvin
Non-Proprietary Name
Griseofulvin
Substance Name
Griseofulvin
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
GRISEOFULVIN 500 mg/1
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
Sigmapharm Laboratories, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA202482
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-06-2012
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 42794-012-08 identifies a specific commercial package of 30 tablet in 1 bottle of Griseofulvin, a human prescription drug labeled by Sigmapharm Laboratories, Llc. This tablet 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 Sigmapharm Laboratories, Llc on December 06, 2012. 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 Sigmapharm Laboratories, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42794001208. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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)
42794-012-08
11-Digit CMS (5-4-2)
42794-0012-08

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