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  5. NDC Package Code: 42794-014-08 Ultramicrosize Griseofulvin

NDC Package 42794-014-08 Ultramicrosize Griseofulvin

Tablet 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:
42794-014-08
Package Description:
30 TABLET in 1 BOTTLE
Product Code:
42794-014
Proprietary Name:
Ultramicrosize Griseofulvin
Non-Proprietary Name:
Ultramicrosize Griseofulvin
Substance Name:
Griseofulvin
Usage Information:
Ultramicrosize Griseofulvin Tablets, USP 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:
42794001408
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
30 EA
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:
    Sigmapharm Laboratories, Llc
    Dosage Form:
    Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • GRISEOFULVIN 250 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:
    ANDA202545
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    11-15-2012
    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.

    Frequently Asked Questions

    What is NDC 42794-014-08?

    The NDC Packaged Code 42794-014-08 is assigned to a package of 30 tablet in 1 bottle of Ultramicrosize Griseofulvin, a human prescription drug labeled by Sigmapharm Laboratories, Llc. The product's dosage form is tablet and is administered via oral form.

    Is NDC 42794-014 included in the NDC Directory?

    Yes, Ultramicrosize Griseofulvin with product code 42794-014 is active and included in the NDC Directory. The product was first marketed by Sigmapharm Laboratories, Llc on November 15, 2012 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 NDC billing unit for package 42794-014-08?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 30.

    What is the 11-digit format for NDC 42794-014-08?

    The 11-digit format is 42794001408. 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
    5-3-242794-014-085-4-242794-0014-08