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NDC 00069-1531-30 Daurismo 100 mg/1 Details

Daurismo 100 mg/1

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.

MedlinePlus Drug Summary

Glasdegib is used along with cytarabine as a first treatment for acute myeloid leukemia (AML; a type of cancer that begins in the white blood cells) in people over 75 years of age, or in adults who have other medical conditions and can not be treated with other chemotherapy medications. Glasdegib is in a class of medications called hedgehog pathway inhibitors. It works by blocking the action of a protein that signals cancer cells to multiply. This helps stop or slow the spread of cancer cells.

Related Packages: 00069-1531-30
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Glasdegib

Product Information

NDC	00069-1531
Product ID	0069-1531_9695bbad-259b-4ac3-80af-36f1ca94d433
Associated GPIs	21370030300335
GCN Sequence Number	079314
GCN Sequence Number Description	glasdegib maleate TABLET 100 MG ORAL
HIC3	V3M
HIC3 Description	ANTINEOPLASTIC - HEDGEHOG PATHWAY INHIBITOR
GCN	45798
HICL Sequence Number	045502
HICL Sequence Number Description	GLASDEGIB MALEATE
Brand/Generic	Brand
Proprietary Name	Daurismo
Proprietary Name Suffix	n/a
Non-Proprietary Name	glasdegib
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	100
Active Ingredient Units	mg/1
Substance Name	GLASDEGIB
Labeler Name	Pfizer Laboratories Div Pfizer Inc
Pharmaceutical Class	Hedgehog Pathway Inhibitor [EPC], Smoothened Receptor Antagonists [MoA]
DEA Schedule	n/a
Marketing Category	NDA
Application Number	NDA210656
Listing Certified Through	2024-12-31

Package

NDC 00069-1531-30 (00069153130)

Pricing Information	N/A
NDC Package Code	0069-1531-30
Billing NDC	00069153130
Package	30 TABLET, FILM COATED in 1 BOTTLE (0069-1531-30)
Marketing Start Date	2018-12-10
NDC Exclude Flag	N