NDC 42794-012

Griseofulvin

Griseofulvin

Griseofulvin is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Sigmapharm Laboratories, Llc. The primary component is Griseofulvin.

Product ID42794-012_89574010-4274-0d72-e053-2995a90a5295
NDC42794-012
Product TypeHuman Prescription Drug
Proprietary NameGriseofulvin
Generic NameGriseofulvin
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2012-12-06
Marketing CategoryANDA / ANDA
Application NumberANDA202482
Labeler NameSigmapharm Laboratories, LLC
Substance NameGRISEOFULVIN
Active Ingredient Strength500 mg/1
Pharm ClassesDecreased Mitosis [PE],Microtubule Inhibition [PE],Tubulin Inhibiting Agent [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 42794-012-08

30 TABLET in 1 BOTTLE (42794-012-08)
Marketing Start Date2016-07-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42794-012-08 [42794001208]

Griseofulvin TABLET
Marketing CategoryANDA
Application NumberANDA202482
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-07-01

Drug Details

Active Ingredients

IngredientStrength
GRISEOFULVIN500 mg/1

OpenFDA Data

SPL SET ID:5bafb97f-621b-4b96-a787-68e0bb5c8637
Manufacturer
UNII
UPC Code
  • 0342794012082

    • Pharmacological Class

    • Decreased Mitosis [PE]
    • Microtubule Inhibition [PE]
    • Tubulin Inhibiting Agent [EPC]
    • Decreased Mitosis [PE]
    • Microtubule Inhibition [PE]
    • Tubulin Inhibiting Agent [EPC]

    NDC Crossover Matching brand name "Griseofulvin" or generic name "Griseofulvin"

    NDCBrand NameGeneric Name
    0472-0013GriseofulvinGriseofulvin
    0713-0850GriseofulvinGriseofulvin
    0781-5514GriseofulvinGriseofulvin
    0781-5515GriseofulvinGriseofulvin
    42794-012GriseofulvinGriseofulvin
    42794-013GriseofulvinGriseofulvin
    42794-014GriseofulvinGriseofulvin
    62135-968GriseofulvinGriseofulvin (microsize)
    64980-184GriseofulvinGriseofulvin
    64980-185GriseofulvinGriseofulvin
    64980-186GriseofulvinGriseofulvin
    68682-519GriseofulvinGriseofulvin
    68682-520GriseofulvinGriseofulvin
    0884-0763Gris-PEGgriseofulvin
    0884-0773Gris-PEGgriseofulvin
    53808-0261Gris-PEGGRISEOFULVIN
    62135-496Griseofulvin MICROSIZEgriseofulvin
    62135-494Ultramicrosize GriseofulvinGriseofulvin
    62135-495Ultramicrosize GriseofulvinGriseofulvin
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.