Griseofulvin Microsize Tablet
NDC Package 62135-496-01

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

Package Information

Griseofulvin Microsize (griseofulvin) tablets is griseofulvin tablets, USP are indicated for the treatment of dermatophyte infections of the skin not adequately treated by topical therapy, hair and nails, namely:Tinea corporisTinea pedisTinea crurisTinea barbaeTinea capitisTinea unguium when caused by one or more of the following species of fungi:Epidermophyton floccosumMicrosporum audouiniiMicrosporum canisMicrosporum gypseumTrichophyton crateriformTrichophyton gallinaeTrichophyton interdigitalisTrichophyton megniniTrichophyton mentagrophytesTrichophyton rubrumTrichophyton schoenleiniTrichophyton sulphureumTrichophyton tonsuransTrichophyton verrucosumNote: Prior to therapy, a dermatophyte should be identified as responsible for the infection.Prior to initiating treatment, appropriate specimens for laboratory testing (KOH preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis.Griseofulvin tablets, USP are not effective in the following:Bacterial infectionsCandidiasis (Moniliasis)HistoplasmosisActinomycosisSporotrichosisChromoblastomycosisCoccidioidomycosisNorth American BlastomycosisCryptococcosis (Torulosis)Tinea versicolorNocardiosisThe use of this drug is not justified in minor or trivial dermatophyte infections which will respond to topical agents alone. This formulation utilizes a tablet delivery system. Marketed by Chartwell Rx, Llc., this product is identified by NDC 62135-496 and is authorized under FDA application ANDA060569.

Identification & Billing

NDC Package Code
62135-496-01
Package Description
100 TABLET in 1 BOTTLE
Product Code
62135-496
11-Digit Billing Format
62135049601
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk
RxCUI: 310600 - griseofulvin 500 MG Oral Tablet

Clinical Specifications

Proprietary Name
Griseofulvin Microsize
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
Griseofulvin tablets, USP are indicated for the treatment of dermatophyte infections of the skin not adequately treated by topical therapy, hair and nails, namely:Tinea corporisTinea pedisTinea crurisTinea barbaeTinea capitisTinea unguium when caused by one or more of the following species of fungi:Epidermophyton floccosumMicrosporum audouiniiMicrosporum canisMicrosporum gypseumTrichophyton crateriformTrichophyton gallinaeTrichophyton interdigitalisTrichophyton megniniTrichophyton mentagrophytesTrichophyton rubrumTrichophyton schoenleiniTrichophyton sulphureumTrichophyton tonsuransTrichophyton verrucosumNote: Prior to therapy, a dermatophyte should be identified as responsible for the infection.Prior to initiating treatment, appropriate specimens for laboratory testing (KOH preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis.Griseofulvin tablets, USP are not effective in the following:Bacterial infectionsCandidiasis (Moniliasis)HistoplasmosisActinomycosisSporotrichosisChromoblastomycosisCoccidioidomycosisNorth American BlastomycosisCryptococcosis (Torulosis)Tinea versicolorNocardiosisThe use of this drug is not justified in minor or trivial dermatophyte infections which will respond to topical agents alone.

Regulatory & Marketing

Labeler Name
Chartwell Rx, Llc.
Product Type
Human Prescription Drug
FDA Application #
ANDA060569
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-09-1971
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (62135-496). Click a package code to view its specific billing and regulatory data.

62135-496-30
30 TABLET in 1 BOTTLE

* 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 62135-496-01 identifies a specific commercial package of 100 tablet in 1 bottle of Griseofulvin Microsize, 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 September 09, 1971. 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: 62135049601. 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)
62135-496-01
11-Digit CMS (5-4-2)
62135-0496-01

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