Grisofulvin Suspension
NDC Package 69097-361-08

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

Package Information

Grisofulvin suspension is griseofulvin oral suspension is 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 crateriformisTrichophyton 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 is not effective in the following:Bacterial infections                             CoccidioidomycosisCandidiasis (Moniliasis)                      North American BlastomycosisHistoplasmosis                                                Cryptococcosis (Torulosis)Actinomycosis                                                Tinea versicolorSporotrichosis                                     NocardiosisChromoblastomycosisThe use of this drug is not justified in minor or trivial dermatophyte infections which will respond to topical agents alone. This formulation utilizes a suspension delivery system. Marketed by Cipla Usa Inc., this product is identified by NDC 69097-361 and is authorized under FDA application ANDA065354.

Identification & Billing

NDC Package Code
69097-361-08
Package Description
120 mL in 1 BOTTLE
Product Code
69097-361
11-Digit Billing Format
69097036108
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
120 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Grisofulvin
Non-Proprietary Name
Grisofulvin
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
Griseofulvin oral suspension is 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 crateriformisTrichophyton 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 is not effective in the following:Bacterial infections                             CoccidioidomycosisCandidiasis (Moniliasis)                      North American BlastomycosisHistoplasmosis                                                Cryptococcosis (Torulosis)Actinomycosis                                                Tinea versicolorSporotrichosis                                     NocardiosisChromoblastomycosisThe use of this drug is not justified in minor or trivial dermatophyte infections which will respond to topical agents alone.

Regulatory & Marketing

Labeler Name
Cipla Usa Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA065354
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-06-2017
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.

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Frequently Asked Questions

What is the distribution configuration for this product package?

The code 69097-361-08 identifies a specific commercial package of 120 ml in 1 bottle of Grisofulvin, a human prescription drug labeled by Cipla Usa 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 Cipla Usa Inc. on March 06, 2017. The current certification is valid through December 31, 2026.

How is this Cipla Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69097036108. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 120 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)
69097-361-08
11-Digit CMS (5-4-2)
69097-0361-08

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