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 ID0078-0694_65871d4e-28af-4cda-8257-7040e34fa80e
NDC0078-0694
Product TypeHuman Prescription Drug
Proprietary NameZYKADIA
Generic NameCeritinib
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-03-18
Marketing CategoryNDA / NDA
Application NumberNDA211225
Labeler NameNovartis Pharmaceuticals Corporation
Substance NameCERITINIB
Active Ingredient Strength150 mg/1
Pharm ClassesKinase Inhibitor [EPC],Tyrosine Kinase Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0078-0694-48

21 TABLET, FILM COATED in 1 BOTTLE (0078-0694-48)
Marketing Start Date2019-03-18
NDC Exclude FlagN
Sample Package?Y

NDC SPL Data Element Entries

NDC 0078-0694-48 [00078069448]

ZYKADIA TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA211225
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-03-18

NDC 0078-0694-84 [00078069484]

ZYKADIA TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA211225
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-03-18

Drug Details

Active Ingredients

IngredientStrength
CERITINIB150 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"

NDCBrand NameGeneric Name
0078-0640ZYKADIAceritinib
0078-0694ZYKADIAceritinib

Trademark Results [ZYKADIA]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ZYKADIA
ZYKADIA
86036708 4804580 Live/Registered
Novartis AG
2013-08-13

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