NDC 53808-0261

Gris-PEG

Griseofulvin

Gris-PEG is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by State Of Florida Doh Central Pharmacy. The primary component is Griseofulvin.

Product ID53808-0261_95cbdf47-932d-40d3-bc1d-e055170711d6
NDC53808-0261
Product TypeHuman Prescription Drug
Proprietary NameGris-PEG
Generic NameGriseofulvin
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2009-07-01
Marketing CategoryNDA / NDA
Application NumberNDA050475
Labeler NameState of Florida DOH Central Pharmacy
Substance NameGRISEOFULVIN
Active Ingredient Strength250 mg/1
Pharm ClassesDecreased Mitosis [PE],Microtubule Inhibition [PE],Tubulin Inhibiting Agent [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 53808-0261-1

30 TABLET, FILM COATED in 1 BLISTER PACK (53808-0261-1)
Marketing Start Date2009-07-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53808-0261-1 [53808026101]

Gris-PEG TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA050475
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-07-01
Inactivation Date2019-10-21

Drug Details

Active Ingredients

IngredientStrength
GRISEOFULVIN250 mg/1

OpenFDA Data

SPL SET ID:9ddd37f9-299e-4c98-91ed-deeb72c63b00
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 205906
  • 239239
    • UPC Code
  • 0308840773048

    • 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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