zykadia

Generic: ceritinib

Labeler: novartis pharmaceuticals corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name zykadia
Generic Name ceritinib
Labeler novartis pharmaceuticals corporation
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ceritinib 150 mg/1

Manufacturer
Novartis Pharmaceuticals Corporation

Identifiers & Regulatory

Product NDC 0078-0694
Product ID 0078-0694_8c405b95-6d3c-4bc5-9b01-2feb80903756
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA211225
Listing Expiration 2026-12-31
Marketing Start 2019-03-18

Pharmacologic Class

Established (EPC)
kinase inhibitor [epc]
Mechanism of Action
tyrosine kinase inhibitors [moa] cytochrome p450 3a inhibitors [moa] cytochrome p450 2c9 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00780694
Hyphenated Format 0078-0694

Supplemental Identifiers

RxCUI
2121059 2121061
UNII
K418KG2GET
NUI
N0000175605 N0000020001 N0000190114 N0000185504

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name zykadia (source: ndc)
Generic Name ceritinib (source: ndc)
Application Number NDA211225 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 21 TABLET, FILM COATED in 1 BOTTLE (0078-0694-48)
  • 84 TABLET, FILM COATED in 1 BOTTLE (0078-0694-84)
source: ndc

Packages (2)

0078-0694-48 21 TABLET, FILM COATED in 1 BOTTLE (0078-0694-48) 0078-0694-84 84 TABLET, FILM COATED in 1 BOTTLE (0078-0694-84)

Ingredients (1)

ceritinib (150 mg/1)

Linked Drug Pages (1)

ZYKADIA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8c405b95-6d3c-4bc5-9b01-2feb80903756", "openfda": {"nui": ["N0000175605", "N0000020001", "N0000190114", "N0000185504"], "unii": ["K418KG2GET"], "rxcui": ["2121059", "2121061"], "spl_set_id": ["fff5d805-4ffd-4e8e-8e63-6f129697563e"], "pharm_class_epc": ["Kinase Inhibitor [EPC]"], "pharm_class_moa": ["Tyrosine Kinase Inhibitors [MoA]", "Cytochrome P450 3A Inhibitors [MoA]", "Cytochrome P450 2C9 Inhibitors [MoA]"], "manufacturer_name": ["Novartis Pharmaceuticals Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "21 TABLET, FILM COATED in 1 BOTTLE (0078-0694-48)", "package_ndc": "0078-0694-48", "marketing_start_date": "20190318"}, {"sample": false, "description": "84 TABLET, FILM COATED in 1 BOTTLE (0078-0694-84)", "package_ndc": "0078-0694-84", "marketing_start_date": "20190318"}], "brand_name": "ZYKADIA", "product_id": "0078-0694_8c405b95-6d3c-4bc5-9b01-2feb80903756", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 2C9 Inhibitors [MoA]", "Cytochrome P450 3A Inhibitors [MoA]", "Kinase Inhibitor [EPC]", "Tyrosine Kinase Inhibitors [MoA]"], "product_ndc": "0078-0694", "generic_name": "ceritinib", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ZYKADIA", "active_ingredients": [{"name": "CERITINIB", "strength": "150 mg/1"}], "application_number": "NDA211225", "marketing_category": "NDA", "marketing_start_date": "20190318", "listing_expiration_date": "20261231"}