NDC 0078-0694

ZYKADIA

Ceritinib

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.

• Product ID: 0078-0694_65871d4e-28af-4cda-8257-7040e34fa80e
• NDC: 0078-0694
• Product Type: Human Prescription Drug
• Proprietary Name: ZYKADIA
• Generic Name: Ceritinib
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2019-03-18
• Marketing Category: NDA / NDA
• Application Number: NDA211225
• Labeler Name: Novartis Pharmaceuticals Corporation
• Substance Name: CERITINIB
• Active Ingredient Strength: 150 mg/1
• Pharm Classes: Kinase Inhibitor [EPC],Tyrosine Kinase Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0078-0694-48

21 TABLET, FILM COATED in 1 BOTTLE (0078-0694-48)

• Marketing Start Date: 2019-03-18
• NDC Exclude Flag: N
• Sample Package?: Y

NDC SPL Data Element Entries

NDC 0078-0694-48 [00078069448]

ZYKADIA TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA211225
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-03-18

NDC 0078-0694-84 [00078069484]

ZYKADIA TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA211225
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-03-18

Drug Details

Active Ingredients

Ingredient	Strength
CERITINIB	150 mg/1

Pharmacological Class

• Kinase Inhibitor [EPC]
• Tyrosine Kinase Inhibitors [MoA]
• Cytochrome P450 3A Inhibitors [MoA]
• Cytochrome P450 2C9 Inhibitors [MoA]

NDC Crossover Matching brand name "ZYKADIA" or generic name "Ceritinib"

NDC	Brand Name	Generic Name
0078-0640	ZYKADIA	ceritinib
0078-0694	ZYKADIA	ceritinib