Home NDC 0078-0694 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 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…2022-10-28 04:53 UTC 2022-10 N211225-001 ZYKADIA 150MG TABLET / ORAL RLD, RS 2019-03-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N211225-001 ZYKADIA 150MG TABLET / ORAL RLD, RS 2019-03-18 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N211225-001 ZYKADIA 150MG TABLET / ORAL RLD, RS 2019-03-18 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 10 · 384 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 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…2025-08-23 18:47 UTC 2025-08 N211225-001 7893074 2026-04-25 Drug substance, Drug product 2019-08-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211225-001 8377921 2027-11-20 U-1179 2019-08-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211225-001 8399450 2027-11-20 Drug substance, Drug product 2019-08-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211225-001 7964592 2028-04-29 Drug substance, Drug product 2019-08-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211225-001 8039479 2030-06-29 Drug substance, Drug product 2019-08-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211225-001 9309229 2032-01-18 Drug substance, Drug product 2019-08-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211225-001 8703787 2032-02-02 U-1179 2019-08-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211225-001 12357630 2037-12-13 U-3096 2025-07-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211225-001 7893074 2026-04-25 Drug substance, Drug product 2019-08-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211225-001 8377921 2027-11-20 U-1179 2019-08-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211225-001 8399450 2027-11-20 Drug substance, Drug product 2019-08-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211225-001 7964592 2028-04-29 Drug substance, Drug product 2019-08-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211225-001 8039479 2030-06-29 Drug substance, Drug product 2019-08-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211225-001 9309229 2032-01-18 Drug substance, Drug product 2019-08-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211225-001 8703787 2032-02-02 U-1179 2019-08-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211225-001 7893074 2026-04-25 Drug substance, Drug product 2019-08-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211225-001 8377921 2027-11-20 U-1179 2019-08-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211225-001 8399450 2027-11-20 Drug substance, Drug product 2019-08-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211225-001 7964592 2028-04-29 Drug substance, Drug product 2019-08-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211225-001 8039479 2030-06-29 Drug substance, Drug product 2019-08-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211225-001 9309229 2032-01-18 Drug substance, Drug product 2019-08-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211225-001 8703787 2032-02-02 U-1179 2019-08-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211225-001 7893074 2026-04-25 Drug substance, Drug product 2019-08-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211225-001 8377921 2027-11-20 U-1179 2019-08-02 03ed91905a0d…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base ZYKADIA
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CERITINIB 150 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination K418KG2GET Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2121059 Internal RxNorm lookup 2121061 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# 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 Socrata Ingredients# 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
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ZYKADIA CERITINIB Novartis Pharmaceuticals Corporation fff5d805-4ffd-4e8e-8e63-6f129697563e 2025-12-15 Warnings, Adverse reactions Exact identifier application applno (NDA): 211225 application number: NDA211225 ndc (product): 0078-0694
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0078-0694-48 00078069448 21 TABLET, FILM COATED in 1 BOTTLE (0078-0694-48) 2019-03-18 0000-00-00 Yes No Current 0078-0694-84 00078069484 84 TABLET, FILM COATED in 1 BOTTLE (0078-0694-84) 2019-03-18 0000-00-00 No No Current