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NDC 00078-0694-48 ZYKADIA 150 mg/1 Details

ZYKADIA 150 mg/1

ZYKADIA is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is CERITINIB.

MedlinePlus Drug Summary

Ceritinib is used to treat a certain type of non-small cell lung cancer (NSCLC) that has spread to other parts of the body. Ceritinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells.

Related Packages: 00078-0694-48
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Ceritinib

Product Information

NDC	00078-0694
Product ID	0078-0694_3db5cf0c-11a3-42f6-bfd0-2c7592470d1b
Associated GPIs	21530514000330
GCN Sequence Number	079591
GCN Sequence Number Description	ceritinib TABLET 150 MG ORAL
HIC3	V1Q
HIC3 Description	ANTINEOPLASTIC SYSTEMIC ENZYME INHIBITORS
GCN	46119
HICL Sequence Number	041111
HICL Sequence Number Description	CERITINIB
Brand/Generic	Brand
Proprietary Name	ZYKADIA
Proprietary Name Suffix	n/a
Non-Proprietary Name	ceritinib
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	150
Active Ingredient Units	mg/1
Substance Name	CERITINIB
Labeler Name	Novartis Pharmaceuticals Corporation
Pharmaceutical Class	Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Kinase Inhibitor [EPC], Tyrosine Kinase Inhibitors [MoA]
DEA Schedule	n/a
Marketing Category	NDA
Application Number	NDA211225
Listing Certified Through	2024-12-31

Package

NDC 00078-0694-48 (00078069448)

Pricing Information	N/A
NDC Package Code	0078-0694-48
Billing NDC	00078069448
Package	21 TABLET, FILM COATED in 1 BOTTLE (0078-0694-48)
Marketing Start Date	2019-03-18
NDC Exclude Flag	N