NDC 0078-0640

ZYKADIA

Ceritinib

ZYKADIA is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals . The primary component is Ceritinib.

• Product ID: 0078-0640_9b71d22d-d9ac-46ff-8cb5-7339cc225b54
• NDC: 0078-0640
• Product Type: Human Prescription Drug
• Proprietary Name: ZYKADIA
• Generic Name: Ceritinib
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2014-04-29
• Marketing Category: NDA / NDA
• Application Number: NDA205755
• Labeler Name: Novartis Pharmaceuticals
• Substance Name: CERITINIB
• Active Ingredient Strength: 150 mg/1
• Pharm Classes: Kinase Inhibito
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0078-0640-70

70 CAPSULE in 1 BOTTLE (0078-0640-70)

• Marketing Start Date: 2014-04-29
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0078-0640-70 [00078064070]

ZYKADIA CAPSULE

• Marketing Category: NDA
• Application Number: NDA205755
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-04-29

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