ZYKADIA

Product NDC: 0078-0694
Requested package NDC: 0078-0694-84
11-digit product format: 000780694
Labeler code: 0078
Product ID: 0078-0694_789c3dff-9742-4f6b-bede-3f47177dd8fe
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N211225-001	ZYKADIA	CERITINIB	150MG	TABLET / ORAL		RLD, RS	2019-03-18

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N211225-001	7893074	2026-04-25		Drug substance, Drug product	2019-08-02
N211225-001	8377921	2027-11-20	U-1179		2019-08-02
N211225-001	8399450	2027-11-20		Drug substance, Drug product	2019-08-02
N211225-001	7964592	2028-04-29		Drug substance, Drug product	2019-08-02
N211225-001	8039479	2030-06-29		Drug substance, Drug product	2019-08-02
N211225-001	9309229	2032-01-18		Drug substance, Drug product	2019-08-02
N211225-001	8703787	2032-02-02	U-1179		2019-08-02
N211225-001	12357630	2037-12-13	U-3096		2025-07-28

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`3a93d1ddd44b…`

Observed Orange Book patent history#

Patent history page 1 of 11 · 408 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N211225-001	7893074	2026-04-25		Drug substance, Drug product	2019-08-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N211225-001	8377921	2027-11-20	U-1179		2019-08-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N211225-001	8399450	2027-11-20		Drug substance, Drug product	2019-08-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N211225-001	7964592	2028-04-29		Drug substance, Drug product	2019-08-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N211225-001	8039479	2030-06-29		Drug substance, Drug product	2019-08-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N211225-001	9309229	2032-01-18		Drug substance, Drug product	2019-08-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N211225-001	8703787	2032-02-02	U-1179		2019-08-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N211225-001	12357630	2037-12-13	U-3096		2025-07-28	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N211225-001	7893074	2026-04-25		Drug substance, Drug product	2019-08-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211225-001	8377921	2027-11-20	U-1179		2019-08-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211225-001	8399450	2027-11-20		Drug substance, Drug product	2019-08-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211225-001	7964592	2028-04-29		Drug substance, Drug product	2019-08-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211225-001	8039479	2030-06-29		Drug substance, Drug product	2019-08-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211225-001	9309229	2032-01-18		Drug substance, Drug product	2019-08-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211225-001	8703787	2032-02-02	U-1179		2019-08-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211225-001	12357630	2037-12-13	U-3096		2025-07-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N211225-001	7893074	2026-04-25		Drug substance, Drug product	2019-08-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211225-001	8377921	2027-11-20	U-1179		2019-08-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211225-001	8399450	2027-11-20		Drug substance, Drug product	2019-08-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211225-001	7964592	2028-04-29		Drug substance, Drug product	2019-08-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211225-001	8039479	2030-06-29		Drug substance, Drug product	2019-08-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211225-001	9309229	2032-01-18		Drug substance, Drug product	2019-08-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211225-001	8703787	2032-02-02	U-1179		2019-08-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211225-001	12357630	2037-12-13	U-3096		2025-07-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211225-001	7893074	2026-04-25		Drug substance, Drug product	2019-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211225-001	8377921	2027-11-20	U-1179		2019-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211225-001	8399450	2027-11-20		Drug substance, Drug product	2019-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211225-001	7964592	2028-04-29		Drug substance, Drug product	2019-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211225-001	8039479	2030-06-29		Drug substance, Drug product	2019-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211225-001	9309229	2032-01-18		Drug substance, Drug product	2019-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211225-001	8703787	2032-02-02	U-1179		2019-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211225-001	12357630	2037-12-13	U-3096		2025-07-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211225-001	7893074	2026-04-25		Drug substance, Drug product	2019-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211225-001	8377921	2027-11-20	U-1179		2019-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211225-001	8399450	2027-11-20		Drug substance, Drug product	2019-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211225-001	7964592	2028-04-29		Drug substance, Drug product	2019-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211225-001	8039479	2030-06-29		Drug substance, Drug product	2019-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211225-001	9309229	2032-01-18		Drug substance, Drug product	2019-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211225-001	8703787	2032-02-02	U-1179		2019-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211225-001	12357630	2037-12-13	U-3096		2025-07-28	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211225-001	ODE*	2024-05-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211225-001	ODE*	2024-05-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211225-001	ODE*	2024-05-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211225-001	ODE*	2024-05-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211225-001	ODE*	2024-05-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211225-001	ODE*	2024-05-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211225-001	ODE*	2024-05-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211225-001	ODE*	2024-05-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211225-001	ODE*	2024-05-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211225-001	ODE*	2024-05-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211225-001	ODE*	2024-05-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211225-001	ODE*	2024-05-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N211225-001	NCE	2019-04-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N211225-001	ODE*	2024-05-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N211225-001	ODE*	2021-04-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N211225-001	ODE*	2024-05-26	`782e0a99824c…`
2019-12-14 00:12 UTC	2019-12	N211225-001	NCE	2019-04-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N211225-001	NCE	2019-04-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N211225-001	NCE	2019-04-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N211225-001	ODE*	2024-05-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N211225-001	ODE*	2024-05-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N211225-001	ODE*	2024-05-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211225-001	ODE*	2024-05-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N211225-001	ODE*	2024-05-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N211225-001	ODE*	2024-05-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N211225-001	ODE*	2024-05-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N211225-001	ODE*	2024-05-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N211225-001	ODE*	2024-05-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N211225-001	ODE*	2024-05-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N211225-001	ODE*	2024-05-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N211225-001	ODE*	2024-05-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N211225-001	ODE*	2024-05-26	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: ZYKADIA
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CERITINIB	150 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0f03cd94-122d-4339-a3df-568527b08ff0	Product name	1	20190627
777cb8b7-53e0-4c36-9d6e-01d51daecf62	Product name	1	20170724

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0078-0694-48	ZYKADIA	21 in 1 BOTTLE	TABLET, FILM COATED	21		21
0078-0694-84	ZYKADIA	84 in 1 BOTTLE	TABLET, FILM COATED	84		21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0078-0694-84	EA - Each	0078-0694	530a7e75-daf0-4bb2-a49b-d98544d54e9c	1	2019-06-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CERITINIB	ACTIVE INGREDIENT	K418KG2GET	ZYKADIA (CERITINIB) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]	2
CERITINIB	ACTIVE MOIETY	K418KG2GET	ZYKADIA (CERITINIB) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ZYKADIA (CERITINIB) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ZYKADIA (CERITINIB) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ZYKADIA (CERITINIB) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]	2
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	ZYKADIA (CERITINIB) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ZYKADIA (CERITINIB) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ZYKADIA (CERITINIB) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ZYKADIA (CERITINIB) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ZYKADIA (CERITINIB) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0078-0694	ZYKADIA (CERITINIB) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]	20	Current NDC, Legacy NDC, 2 package rows	20250210_fff5d805-4ffd-4e8e-8e63-6f129697563e.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
K418KG2GET	CERITINIB	1032900-25-6	CERITINIB

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2121059	ceritinib 150 MG Oral Tablet	PSN	fff5d805-4ffd-4e8e-8e63-6f129697563e	21
2121061	Zykadia 150 MG Oral Tablet	PSN	fff5d805-4ffd-4e8e-8e63-6f129697563e	21
2121061	ceritinib 150 MG Oral Tablet [Zykadia]	SBD	fff5d805-4ffd-4e8e-8e63-6f129697563e	21
2121059	ceritinib 150 MG Oral Tablet	SCD	fff5d805-4ffd-4e8e-8e63-6f129697563e	21
2121061	Zykadia 150 MG Oral Tablet	SY	fff5d805-4ffd-4e8e-8e63-6f129697563e	21

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0078-0694-84	00078069484	84 TABLET, FILM COATED in 1 BOTTLE (0078-0694-84)	2019-03-18	0000-00-00	No	No	Current