NDC 0884-0763

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 ID: 0884-0763_d3d67926-0727-496e-b54c-d6c8770f84d6
• NDC: 0884-0763
• Product Type: Human Prescription Drug
• Proprietary Name: Gris-PEG
• Generic Name: Griseofulvin
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2016-07-26
• Marketing Category: NDA / NDA
• Application Number: NDA050475
• Labeler Name: Pedinol Pharmacal, Inc.
• Substance Name: GRISEOFULVIN
• Active Ingredient Strength: 125 mg/1
• Pharm Classes: Decreased Mitosis [PE],Microtubule Inhibition [PE],Tubulin Inhibiting Agent [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0884-0763-04

100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0884-0763-04)

• Marketing Start Date: 2016-07-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0884-0763-04 [00884076304]

Gris-PEG TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA050475
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-07-26
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
GRISEOFULVIN	125 mg/1

OpenFDA Data

• SPL SET ID: 20aa6571-ee10-4dc1-9be9-018aa0a680fc
• Manufacturer:
  • Pedinol Pharmacal, Inc.
• UNII:
  • 32HRV3E3D5
• 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"

NDC	Brand Name	Generic Name
0884-0763	Gris-PEG	griseofulvin
0884-0773	Gris-PEG	griseofulvin
53808-0261	Gris-PEG	GRISEOFULVIN
0472-0013	Griseofulvin	Griseofulvin
0713-0850	Griseofulvin	Griseofulvin
0781-5514	Griseofulvin	Griseofulvin
0781-5515	Griseofulvin	Griseofulvin
42794-012	Griseofulvin	Griseofulvin
42794-013	Griseofulvin	Griseofulvin
42794-014	Griseofulvin	Griseofulvin
64980-184	Griseofulvin	Griseofulvin
64980-185	Griseofulvin	Griseofulvin
64980-186	Griseofulvin	Griseofulvin
68682-519	Griseofulvin	Griseofulvin
68682-520	Griseofulvin	Griseofulvin
62135-496	Griseofulvin MICROSIZE	griseofulvin
62135-494	Ultramicrosize Griseofulvin	Griseofulvin
62135-495	Ultramicrosize Griseofulvin	Griseofulvin