NDC 0781-5827

Ultramicrosize Griseofulvin

Ultramicrosize Griseofulvin

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

Product ID0781-5827_3361b60b-c6a2-422a-863c-c1ee80beb757
NDC0781-5827
Product TypeHuman Prescription Drug
Proprietary NameUltramicrosize Griseofulvin
Generic NameUltramicrosize Griseofulvin
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2020-04-01
Marketing CategoryANDA / ANDA
Application NumberANDA202805
Labeler NameSandoz Inc
Substance NameGRISEOFULVIN
Active Ingredient Strength125 mg/1
Pharm ClassesDecreased Mitosis [PE],Microtubule Inhibition [PE],Tubulin Inhibiting Agent [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0781-5827-01

100 TABLET, COATED in 1 BOTTLE (0781-5827-01)
Marketing Start Date2020-04-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0781-5827-05 [00781582705]

Ultramicrosize Griseofulvin TABLET, COATED
Marketing CategoryANDA
Application NumberANDA202805
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-04-01

NDC 0781-5827-01 [00781582701]

Ultramicrosize Griseofulvin TABLET, COATED
Marketing CategoryANDA
Application NumberANDA202805
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-04-01

Drug Details

Active Ingredients

IngredientStrength
GRISEOFULVIN125 mg/1

OpenFDA Data

SPL SET ID:f4fa0eb9-bd6a-4ea2-b565-e0db88aa1ebd
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 242831
  • 239239
    • UPC Code
  • 0307815827014
  • 0307815828011

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0115-1724Ultramicrosize GriseofulvinUltramicrosize Griseofulvin Tablets
    0115-1725Ultramicrosize GriseofulvinUltramicrosize Griseofulvin Tablets
    0781-5827Ultramicrosize GriseofulvinUltramicrosize Griseofulvin
    0781-5828Ultramicrosize GriseofulvinUltramicrosize Griseofulvin
    42794-013Ultramicrosize GriseofulvinUltramicrosize Griseofulvin
    42794-014Ultramicrosize GriseofulvinUltramicrosize Griseofulvin
    62135-494Ultramicrosize GriseofulvinGriseofulvin
    62135-495Ultramicrosize GriseofulvinGriseofulvin
    64720-295Ultramicrosize GriseofulvinUltramicrosize Griseofulvin Tablets
    64720-296Ultramicrosize GriseofulvinUltramicrosize Griseofulvin Tablets
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.