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  5. NDC Package Code: 69097-361-08 Grisofulvin

NDC Package 69097-361-08 Grisofulvin

Suspension Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
69097-361-08
Package Description:
120 mL in 1 BOTTLE
Product Code:
69097-361
Proprietary Name:
Grisofulvin
Non-Proprietary Name:
Grisofulvin
Substance Name:
Griseofulvin
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.
11-Digit NDC Billing Format:
69097036108
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
120 ML
NDC to RxNorm Crosswalk:
  • RxCUI: 239238 - griseofulvin 125 MG in 5 mL Oral Suspension
  • RxCUI: 239238 - griseofulvin 25 MG/ML Oral Suspension
  • RxCUI: 239238 - griseofulvin 125 MG per 5 ML Oral Suspension
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Cipla Usa Inc.
    Dosage Form:
    Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • GRISEOFULVIN 125 mg/5mL
    • Pharmacologic Class(es):
  • Decreased Mitosis - [PE] (Physiologic Effect)
  • Microtubule Inhibition - [PE] (Physiologic Effect)
  • Tubulin Inhibiting Agent - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA065354
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    03-06-2017
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 69097-361-08?

    The NDC Packaged Code 69097-361-08 is assigned to a package of 120 ml in 1 bottle of Grisofulvin, a human prescription drug labeled by Cipla Usa Inc.. The product's dosage form is suspension and is administered via oral form.

    Is NDC 69097-361 included in the NDC Directory?

    Yes, Grisofulvin with product code 69097-361 is active and included in the NDC Directory. The product was first marketed by Cipla Usa Inc. on March 06, 2017 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 69097-361-08?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume. The calculated billable units for this package is 120.

    What is the 11-digit format for NDC 69097-361-08?

    The 11-digit format is 69097036108. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-269097-361-085-4-269097-0361-08