Ultramicrosize Griseofulvin Tablet
NDC Package 62135-501-30

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

Package Information

Ultramicrosize Griseofulvin tablets are indicated for the treatment of ringworm infections of the skin, hair, and nails, namely: tinea corporis, tinea pedis, tinea cruris, tinea barbae, tinea capitis, tinea unguium (onychomycosis) when caused by one or more of the following genera of fungi: Trichophyton rubrum, Trichophyton tonsurans, Trichophyton mentagrophytes, Trichophyton interdigitale, Trichophyton verrucosum, Trichophyton megninii, Trichophyton gallinae,  Trichophyton crateriforme, Trichophyton sulphureum, Trichophyton schoenieinii, Microsporum audouini, Microsporum canis, Microsporum gypseum, and Epidermophyton floccosum.Note: Prior to therapy, the type of fungi responsible for the infection should be identified.The use of this drug is not justified in minor or trivial infections which will respond to topical agents alone.Griseofulvin is not effective in the following: bacterial infections, candidiasis (moniliasis), histoplasmosis, actinomycosis, sporotrichosis, chromoblastomycosis, coccidioidomycosis, North American blastomycosis, cryptococcosis (torulosis), tinea versicolor, and nocardiosis. This formulation utilizes a tablet delivery system. Marketed by Chartwell Rx, Llc, this product is identified by NDC 62135-501 and is authorized under FDA application ANDA061996.

Identification & Billing

NDC Package Code
62135-501-30
Package Description
30 TABLET in 1 BOTTLE
Product Code
62135-501
11-Digit Billing Format
62135050130
RxNorm Crosswalk
RxCUI: 245248 - griseofulvin 165 MG Oral Tablet

Clinical Specifications

Proprietary Name
Ultramicrosize Griseofulvin
Non-Proprietary Name
Ultramicrosize 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 165 mg/1
Pharmacologic Class
Usage Information
Ultramicrosize griseofulvin tablets are indicated for the treatment of ringworm infections of the skin, hair, and nails, namely: tinea corporis, tinea pedis, tinea cruris, tinea barbae, tinea capitis, tinea unguium (onychomycosis) when caused by one or more of the following genera of fungi: Trichophyton rubrum, Trichophyton tonsurans, Trichophyton mentagrophytes, Trichophyton interdigitale, Trichophyton verrucosum, Trichophyton megninii, Trichophyton gallinae,  Trichophyton crateriforme, Trichophyton sulphureum, Trichophyton schoenieinii, Microsporum audouini, Microsporum canis, Microsporum gypseum, and Epidermophyton floccosum.Note: Prior to therapy, the type of fungi responsible for the infection should be identified.The use of this drug is not justified in minor or trivial infections which will respond to topical agents alone.Griseofulvin is not effective in the following: bacterial infections, candidiasis (moniliasis), histoplasmosis, actinomycosis, sporotrichosis, chromoblastomycosis, coccidioidomycosis, North American blastomycosis, cryptococcosis (torulosis), tinea versicolor, and nocardiosis.

Regulatory & Marketing

Labeler Name
Chartwell Rx, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA061996
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-06-1982
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 62135-501-30 identifies a specific commercial package of 30 tablet in 1 bottle of Ultramicrosize Griseofulvin, a human prescription drug labeled by Chartwell Rx, 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 Chartwell Rx, Llc on April 06, 1982. The current certification is valid through December 31, 2026.

How is this Chartwell Rx, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 62135050130. 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)
62135-501-30
11-Digit CMS (5-4-2)
62135-0501-30

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