ZYKADIA (Page 8 of 8)

PRINCIPAL DISPLAY PANEL

NDC 0078-0694-84

Zykadia®

(ceritinib) tablets

150 mg

84 Tablets

NOVARTIS

Rx only

PRINCIPAL DISPLAY PANEL
								NDC 0078-0694-84
								Zykadia®
								(ceritinib) tablets
								150 mg
								84 Tablets
								NOVARTIS
								Rx Only
(click image for full-size original)
ZYKADIA ceritinib tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0694
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CERITINIB (CERITINIB) CERITINIB 150 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
HYDROXYPROPYL CELLULOSE
POVIDONE K30
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
SILICON DIOXIDE
TALC
TITANIUM DIOXIDE
HYPROMELLOSE, UNSPECIFIED
POLYETHYLENE GLYCOL, UNSPECIFIED
FD&C BLUE NO. 2
Product Characteristics
Color BLUE (light blue) Score no score
Shape ROUND Size 9mm
Flavor Imprint Code NVR;ZY1
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0078-0694-84 84 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:0078-0694-48 21 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA211225 03/18/2019
Labeler — Novartis Pharmaceuticals Corporation (002147023)

Revised: 06/2022 Novartis Pharmaceuticals Corporation

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