FDA.reportPublic FDA data

ZYKADIA

Product NDC
0078-0694
11-digit product format
000780694
Labeler code
0078
Product ID
0078-0694_8c405b95-6d3c-4bc5-9b01-2feb80903756
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ceritinib
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Novartis Pharmaceuticals Corporation
Application
NDA211225
Marketing category
NDA
Marketing start
2019-03-18
Substance
CERITINIB
Active strength
150 mg/1
Pharmacologic classes
Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Kinase Inhibitor [EPC], Tyrosine Kinase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ZYKADIA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CERITINIB150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiK418KG2GET
Rxcui2121059, 2121061

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0f03cd94-122d-4339-a3df-568527b08ff0Product name120190627
777cb8b7-53e0-4c36-9d6e-01d51daecf62Product name120170724

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0078-0694-48ZYKADIA21 in 1 BOTTLETABLET, FILM COATED2121
0078-0694-84ZYKADIA84 in 1 BOTTLETABLET, FILM COATED8421

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0694-84EA - Each0078-0694530a7e75-daf0-4bb2-a49b-d98544d54e9c12019-06-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CERITINIBACTIVE INGREDIENTK418KG2GETZYKADIA (CERITINIB) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]2
CERITINIBACTIVE MOIETYK418KG2GETZYKADIA (CERITINIB) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZYKADIA (CERITINIB) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKZYKADIA (CERITINIB) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]2
GELATININACTIVE INGREDIENT2G86QN327LZYKADIA (CERITINIB) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PZYKADIA (CERITINIB) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZYKADIA (CERITINIB) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ZYKADIA (CERITINIB) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ZYKADIA (CERITINIB) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZYKADIA (CERITINIB) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-0694ZYKADIA (CERITINIB) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]20Current NDC, Legacy NDC, 2 package rows20250210_fff5d805-4ffd-4e8e-8e63-6f129697563e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2121059ceritinib 150 MG Oral TabletPSNfff5d805-4ffd-4e8e-8e63-6f129697563e21
2121061Zykadia 150 MG Oral TabletPSNfff5d805-4ffd-4e8e-8e63-6f129697563e21
2121061ceritinib 150 MG Oral Tablet [Zykadia]SBDfff5d805-4ffd-4e8e-8e63-6f129697563e21
2121059ceritinib 150 MG Oral TabletSCDfff5d805-4ffd-4e8e-8e63-6f129697563e21
2121061Zykadia 150 MG Oral TabletSYfff5d805-4ffd-4e8e-8e63-6f129697563e21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0078-0694-480007806944821 TABLET, FILM COATED in 1 BOTTLE (0078-0694-48) 2019-03-180000-00-00YesNoCurrent
0078-0694-840007806948484 TABLET, FILM COATED in 1 BOTTLE (0078-0694-84) 2019-03-180000-00-00NoNoCurrent