NDC 0069-1531

Daurismo

Glasdegib

Daurismo is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Pfizer Laboratories Div Pfizer Inc. The primary component is Glasdegib.

• Product ID: 0069-1531_1b683310-8e38-4505-acd8-b92006bc2488
• NDC: 0069-1531
• Product Type: Human Prescription Drug
• Proprietary Name: Daurismo
• Generic Name: Glasdegib
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2018-12-10
• Marketing Category: NDA / NDA
• Application Number: NDA210656
• Labeler Name: Pfizer Laboratories Div Pfizer Inc
• Substance Name: GLASDEGIB
• Active Ingredient Strength: 100 mg/1
• Pharm Classes: Hedgehog Pathway Inhibitor [EPC],Smoothened Receptor Antagonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0069-1531-30

30 TABLET, FILM COATED in 1 BOTTLE (0069-1531-30)

• Marketing Start Date: 2018-12-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0069-1531-30 [00069153130]

Daurismo TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA210656
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-12-10

Drug Details

Active Ingredients

Ingredient	Strength
GLASDEGIB	100 mg/1

OpenFDA Data

• SPL SET ID: 204a6f7e-c9a4-472b-abd2-9527bda64d17
• Manufacturer:
  • Pfizer Laboratories Div Pfizer Inc
• UNII:
  • K673DMO5H9
• RxNorm Concept Unique ID - RxCUI:
  • 2105850
  • 2105860
  • 2105856
  • 2105858
• UPC Code:
  • 0300690298603
  • 0300691531303

Pharmacological Class

• Hedgehog Pathway Inhibitor [EPC]
• Smoothened Receptor Antagonists [MoA]

NDC Crossover Matching brand name "Daurismo" or generic name "Glasdegib"

NDC	Brand Name	Generic Name
0069-0298	Daurismo	glasdegib
0069-1531	Daurismo	glasdegib