NDC 0781-5514

Griseofulvin

Griseofulvin

Griseofulvin is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Sandoz Inc. The primary component is Griseofulvin.

Product ID0781-5514_27a575d3-76fb-4ade-bcac-7ced178643bb
NDC0781-5514
Product TypeHuman Prescription Drug
Proprietary NameGriseofulvin
Generic NameGriseofulvin
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2013-08-07
Marketing CategoryANDA / ANDA
Application NumberANDA091592
Labeler NameSandoz Inc
Substance NameGRISEOFULVIN
Active Ingredient Strength250 mg/1
Pharm ClassesDecreased Mitosis [PE],Microtubule Inhibition [PE],Tubulin Inhibiting Agent [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0781-5514-01

100 TABLET in 1 BOTTLE (0781-5514-01)
Marketing Start Date2013-08-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0781-5514-01 [00781551401]

Griseofulvin TABLET
Marketing CategoryANDA
Application NumberANDA091592
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-08-07

NDC 0781-5514-05 [00781551405]

Griseofulvin TABLET
Marketing CategoryANDA
Application NumberANDA091592
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-08-07

Drug Details

Active Ingredients

IngredientStrength
GRISEOFULVIN250 mg/1

OpenFDA Data

SPL SET ID:98829d90-b289-4bec-a625-7af412a5cb2d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310600
  • 239239
    • UPC Code
  • 0307815514013
  • 0307815515010

    • Pharmacological Class

    • 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
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