NDC 0884-0773

Gris-PEG

Griseofulvin

Gris-PEG is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Pedinol Pharmacal, Inc.. The primary component is Griseofulvin.

Product ID0884-0773_d3d67926-0727-496e-b54c-d6c8770f84d6
NDC0884-0773
Product TypeHuman Prescription Drug
Proprietary NameGris-PEG
Generic NameGriseofulvin
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2016-07-26
Marketing CategoryNDA / NDA
Application NumberNDA050475
Labeler NamePedinol Pharmacal, 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 0884-0773-04

100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0884-0773-04)
Marketing Start Date2016-07-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0884-0773-50 [00884077350]

Gris-PEG TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA050475
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2000-06-01
Marketing End Date2013-06-30

NDC 0884-0773-04 [00884077304]

Gris-PEG TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA050475
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-07-26
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
GRISEOFULVIN250 mg/1

OpenFDA Data

SPL SET ID:20aa6571-ee10-4dc1-9be9-018aa0a680fc
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 242831
  • 205906
  • 239239
  • 205904
  • UPC Code
  • 0308840773048
  • 0308840763049
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Gris-PEG" or generic name "Griseofulvin"

    NDCBrand NameGeneric Name
    0884-0763Gris-PEGgriseofulvin
    0884-0773Gris-PEGgriseofulvin
    53808-0261Gris-PEGGRISEOFULVIN
    0472-0013GriseofulvinGriseofulvin
    0713-0850GriseofulvinGriseofulvin
    0781-5514GriseofulvinGriseofulvin
    0781-5515GriseofulvinGriseofulvin
    42794-012GriseofulvinGriseofulvin
    42794-013GriseofulvinGriseofulvin
    42794-014GriseofulvinGriseofulvin
    64980-184GriseofulvinGriseofulvin
    64980-185GriseofulvinGriseofulvin
    64980-186GriseofulvinGriseofulvin
    68682-519GriseofulvinGriseofulvin
    68682-520GriseofulvinGriseofulvin
    62135-496Griseofulvin MICROSIZEgriseofulvin
    62135-494Ultramicrosize GriseofulvinGriseofulvin
    62135-495Ultramicrosize GriseofulvinGriseofulvin

    Trademark Results [Gris-PEG]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    GRIS-PEG
    GRIS-PEG
    73054563 1031165 Live/Registered
    SANDOZ, INC.
    1975-06-09

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