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  5. NDC Package Code: 0781-5827-05 Ultramicrosize Griseofulvin

NDC Package 0781-5827-05 Ultramicrosize Griseofulvin

Tablet, Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
0781-5827-05
Package Description:
500 TABLET, COATED in 1 BOTTLE
Product Code:
0781-5827
Proprietary Name:
Ultramicrosize Griseofulvin
Non-Proprietary Name:
Ultramicrosize Griseofulvin
Substance Name:
Griseofulvin
Usage Information:
Ultramicrosize griseofulvin tablets are indicated for the treatment of the following ringworm infections; tinea corporis (ringworm of the body), tinea pedis (athlete’s foot), tinea cruris (ringworm of the groin and thigh), tinea barbae (barber’s itch), tinea capitis (ringworm of the scalp), and tinea unguium (onychomycosis, ringworm of the nails), when caused by one or more of the following genera of fungi: Trichophyton rubrum, Trichophyton tonsurans, Trichophyton mentagrophytes, Trichophyton  interdigitalis, Trichophyton  verrucosum, Trichophyton  megnini, Trichophyton  gallinae, Trichophyton  crateriform, Trichophyton  sulphureum, Trichophyton  schoenleini, 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 the 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.
11-Digit NDC Billing Format:
00781582705
NDC to RxNorm Crosswalk:
  • RxCUI: 239239 - griseofulvin 250 MG Oral Tablet
  • RxCUI: 242831 - griseofulvin 125 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Sandoz Inc
    Dosage Form:
    Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • GRISEOFULVIN 125 mg/1
    • 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:
    ANDA202805
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    04-01-2020
    Listing Expiration Date:
    12-31-2024
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    0781-5827-01100 TABLET, COATED in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0781-5827-05?

    The NDC Packaged Code 0781-5827-05 is assigned to a package of 500 tablet, coated in 1 bottle of Ultramicrosize Griseofulvin, a human prescription drug labeled by Sandoz Inc. The product's dosage form is tablet, coated and is administered via oral form.

    Is NDC 0781-5827 included in the NDC Directory?

    Yes, Ultramicrosize Griseofulvin with product code 0781-5827 is active and included in the NDC Directory. The product was first marketed by Sandoz Inc on April 01, 2020 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 0781-5827-05?

    The 11-digit format is 00781582705. 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 4-4-2 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
    4-4-20781-5827-055-4-200781-5827-05