TUKYSA

Product NDC
51144-001
11-digit product format
511440001
Labeler code
51144
Product ID
51144-001_8afb8c49-b2fe-43cb-94bf-166f8c139a72
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tucatinib
Dosage form
TABLET
Route
ORAL
Labeler
SEAGEN INC.
Application
NDA213411
Marketing category
NDA
Marketing start
2020-04-17
Substance
TUCATINIB
Active strength
50 mg/1
Pharmacologic classes
Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Kinase Inhibitor [EPC], P-Glycoprotein Inhibitors [MoA], 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N213411-001TUKYSATUCATINIB50MGTABLET / ORALRLD2020-04-17
N213411-002TUKYSATUCATINIB150MGTABLET / ORALRLD, RS2020-04-17

Orange Book patents#

Current patent rows page 1 of 1 · 14 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N213411-00196939892027-05-09U-2788Drug product2020-04-29
N213411-00194570932032-10-12U-2788Drug product2020-04-29
N213411-001115043702033-03-25U-27882022-12-05
N213411-00186480872034-04-17Drug substance, Drug product2020-04-29
N213411-001112073242038-04-27U-37832023-02-02
N213411-001116665722038-04-27U-37832024-01-29
N213411-001120486982038-04-27U-37832024-08-28
N213411-00296939892027-05-09U-2788Drug product2020-04-29
N213411-00294570932032-10-12U-2788Drug product2020-04-29
N213411-002115043702033-03-25U-27882022-12-05
N213411-00286480872034-04-17Drug substance, Drug product2020-04-29
N213411-002112073242038-04-27U-37832023-02-02
N213411-002116665722038-04-27U-37832024-01-29
N213411-002120486982038-04-27U-37832024-08-28

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 6 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N213411-001I-9062026-01-19
N213411-001ODE-3092027-04-17
N213411-001ODE-4222030-01-19
N213411-002I-9062026-01-19
N213411-002ODE-3092027-04-17
N213411-002ODE-4222030-01-19

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 · 80 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N213411-001TUKYSA50MGTABLET / ORALRLD2020-04-17c2088c7a36db…
2026-10-15 13:18:302026-09N213411-002TUKYSA150MGTABLET / ORALRLD, RS2020-04-17c2088c7a36db…
2026-09-14 22:38:342026-08N213411-001TUKYSA50MGTABLET / ORALRLD2020-04-1784e616aacf4f…
2026-09-14 22:38:342026-08N213411-002TUKYSA150MGTABLET / ORALRLD, RS2020-04-1784e616aacf4f…
2026-08-18 06:07:402026-07N213411-001TUKYSA50MGTABLET / ORALRLD2020-04-17caaa826d4ba7…
2026-08-18 06:07:402026-07N213411-002TUKYSA150MGTABLET / ORALRLD, RS2020-04-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N213411-001TUKYSA50MGTABLET / ORALRLD2020-04-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213411-002TUKYSA150MGTABLET / ORALRLD, RS2020-04-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213411-001TUKYSA50MGTABLET / ORALRLD2020-04-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213411-002TUKYSA150MGTABLET / ORALRLD, RS2020-04-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08N213411-001TUKYSA50MGTABLET / ORALRLD2020-04-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213411-002TUKYSA150MGTABLET / ORALRLD, RS2020-04-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N213411-001TUKYSA50MGTABLET / ORALRLD2020-04-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N213411-002TUKYSA150MGTABLET / ORALRLD, RS2020-04-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N213411-001TUKYSA50MGTABLET / ORALRLD2020-04-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N213411-002TUKYSA150MGTABLET / ORALRLD, RS2020-04-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N213411-001TUKYSA50MGTABLET / ORALRLD2020-04-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N213411-002TUKYSA150MGTABLET / ORALRLD, RS2020-04-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N213411-001TUKYSA50MGTABLET / ORALRLD2020-04-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N213411-002TUKYSA150MGTABLET / ORALRLD, RS2020-04-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N213411-001TUKYSA50MGTABLET / ORALRLD2020-04-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N213411-002TUKYSA150MGTABLET / ORALRLD, RS2020-04-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N213411-001TUKYSA50MGTABLET / ORALRLD2020-04-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N213411-002TUKYSA150MGTABLET / ORALRLD, RS2020-04-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N213411-001TUKYSA50MGTABLET / ORALRLD2020-04-17d06236e962d9…
2024-10-29 15:01 UTC2024-10N213411-002TUKYSA150MGTABLET / ORALRLD, RS2020-04-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N213411-001TUKYSA50MGTABLET / ORALRLD2020-04-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N213411-002TUKYSA150MGTABLET / ORALRLD, RS2020-04-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N213411-001TUKYSA50MGTABLET / ORALRLD2020-04-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N213411-002TUKYSA150MGTABLET / ORALRLD, RS2020-04-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N213411-001TUKYSA50MGTABLET / ORALRLD2020-04-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N213411-002TUKYSA150MGTABLET / ORALRLD, RS2020-04-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05N213411-001TUKYSA50MGTABLET / ORALRLD2020-04-178072bd15b7f6…
2024-05-31 18:47 UTC2024-05N213411-002TUKYSA150MGTABLET / ORALRLD, RS2020-04-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N213411-001TUKYSA50MGTABLET / ORALRLD2020-04-175c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N213411-002TUKYSA150MGTABLET / ORALRLD, RS2020-04-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N213411-001TUKYSA50MGTABLET / ORALRLD2020-04-175d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N213411-002TUKYSA150MGTABLET / ORALRLD, RS2020-04-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N213411-001TUKYSA50MGTABLET / ORALRLD2020-04-174b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N213411-002TUKYSA150MGTABLET / ORALRLD, RS2020-04-174b0b4de00fa7…

Observed Orange Book patent history#

Patent history page 1 of 13 · 484 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-10-15 13:18:302026-09N213411-00196939892027-05-09U-2788Drug product2020-04-29c2088c7a36db…
2026-10-15 13:18:302026-09N213411-00194570932032-10-12U-2788Drug product2020-04-29c2088c7a36db…
2026-10-15 13:18:302026-09N213411-001115043702033-03-25U-27882022-12-05c2088c7a36db…
2026-10-15 13:18:302026-09N213411-00186480872034-04-17Drug substance, Drug product2020-04-29c2088c7a36db…
2026-10-15 13:18:302026-09N213411-001112073242038-04-27U-37832023-02-02c2088c7a36db…
2026-10-15 13:18:302026-09N213411-001116665722038-04-27U-37832024-01-29c2088c7a36db…
2026-10-15 13:18:302026-09N213411-001120486982038-04-27U-37832024-08-28c2088c7a36db…
2026-10-15 13:18:302026-09N213411-00296939892027-05-09U-2788Drug product2020-04-29c2088c7a36db…
2026-10-15 13:18:302026-09N213411-00294570932032-10-12U-2788Drug product2020-04-29c2088c7a36db…
2026-10-15 13:18:302026-09N213411-002115043702033-03-25U-27882022-12-05c2088c7a36db…
2026-10-15 13:18:302026-09N213411-00286480872034-04-17Drug substance, Drug product2020-04-29c2088c7a36db…
2026-10-15 13:18:302026-09N213411-002112073242038-04-27U-37832023-02-02c2088c7a36db…
2026-10-15 13:18:302026-09N213411-002116665722038-04-27U-37832024-01-29c2088c7a36db…
2026-10-15 13:18:302026-09N213411-002120486982038-04-27U-37832024-08-28c2088c7a36db…
2026-09-14 22:38:342026-08N213411-00196939892027-05-09U-2788Drug product2020-04-2984e616aacf4f…
2026-09-14 22:38:342026-08N213411-00194570932032-10-12U-2788Drug product2020-04-2984e616aacf4f…
2026-09-14 22:38:342026-08N213411-001115043702033-03-25U-27882022-12-0584e616aacf4f…
2026-09-14 22:38:342026-08N213411-00186480872034-04-17Drug substance, Drug product2020-04-2984e616aacf4f…
2026-09-14 22:38:342026-08N213411-001112073242038-04-27U-37832023-02-0284e616aacf4f…
2026-09-14 22:38:342026-08N213411-001116665722038-04-27U-37832024-01-2984e616aacf4f…
2026-09-14 22:38:342026-08N213411-001120486982038-04-27U-37832024-08-2884e616aacf4f…
2026-09-14 22:38:342026-08N213411-00296939892027-05-09U-2788Drug product2020-04-2984e616aacf4f…
2026-09-14 22:38:342026-08N213411-00294570932032-10-12U-2788Drug product2020-04-2984e616aacf4f…
2026-09-14 22:38:342026-08N213411-002115043702033-03-25U-27882022-12-0584e616aacf4f…
2026-09-14 22:38:342026-08N213411-00286480872034-04-17Drug substance, Drug product2020-04-2984e616aacf4f…
2026-09-14 22:38:342026-08N213411-002112073242038-04-27U-37832023-02-0284e616aacf4f…
2026-09-14 22:38:342026-08N213411-002116665722038-04-27U-37832024-01-2984e616aacf4f…
2026-09-14 22:38:342026-08N213411-002120486982038-04-27U-37832024-08-2884e616aacf4f…
2026-08-18 06:07:402026-07N213411-00196939892027-05-09U-2788Drug product2020-04-29caaa826d4ba7…
2026-08-18 06:07:402026-07N213411-00194570932032-10-12U-2788Drug product2020-04-29caaa826d4ba7…
2026-08-18 06:07:402026-07N213411-001115043702033-03-25U-27882022-12-05caaa826d4ba7…
2026-08-18 06:07:402026-07N213411-00186480872034-04-17Drug substance, Drug product2020-04-29caaa826d4ba7…
2026-08-18 06:07:402026-07N213411-001112073242038-04-27U-37832023-02-02caaa826d4ba7…
2026-08-18 06:07:402026-07N213411-001116665722038-04-27U-37832024-01-29caaa826d4ba7…
2026-08-18 06:07:402026-07N213411-001120486982038-04-27U-37832024-08-28caaa826d4ba7…
2026-08-18 06:07:402026-07N213411-00296939892027-05-09U-2788Drug product2020-04-29caaa826d4ba7…
2026-08-18 06:07:402026-07N213411-00294570932032-10-12U-2788Drug product2020-04-29caaa826d4ba7…
2026-08-18 06:07:402026-07N213411-002115043702033-03-25U-27882022-12-05caaa826d4ba7…
2026-08-18 06:07:402026-07N213411-00286480872034-04-17Drug substance, Drug product2020-04-29caaa826d4ba7…
2026-08-18 06:07:402026-07N213411-002112073242038-04-27U-37832023-02-02caaa826d4ba7…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 7 · 254 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-10-15 13:18:302026-09N213411-001I-9062026-01-19c2088c7a36db…
2026-10-15 13:18:302026-09N213411-001ODE-3092027-04-17c2088c7a36db…
2026-10-15 13:18:302026-09N213411-001ODE-4222030-01-19c2088c7a36db…
2026-10-15 13:18:302026-09N213411-002I-9062026-01-19c2088c7a36db…
2026-10-15 13:18:302026-09N213411-002ODE-3092027-04-17c2088c7a36db…
2026-10-15 13:18:302026-09N213411-002ODE-4222030-01-19c2088c7a36db…
2026-09-14 22:38:342026-08N213411-001I-9062026-01-1984e616aacf4f…
2026-09-14 22:38:342026-08N213411-001ODE-3092027-04-1784e616aacf4f…
2026-09-14 22:38:342026-08N213411-001ODE-4222030-01-1984e616aacf4f…
2026-09-14 22:38:342026-08N213411-002I-9062026-01-1984e616aacf4f…
2026-09-14 22:38:342026-08N213411-002ODE-3092027-04-1784e616aacf4f…
2026-09-14 22:38:342026-08N213411-002ODE-4222030-01-1984e616aacf4f…
2026-08-18 06:07:402026-07N213411-001I-9062026-01-19caaa826d4ba7…
2026-08-18 06:07:402026-07N213411-001ODE-3092027-04-17caaa826d4ba7…
2026-08-18 06:07:402026-07N213411-001ODE-4222030-01-19caaa826d4ba7…
2026-08-18 06:07:402026-07N213411-002I-9062026-01-19caaa826d4ba7…
2026-08-18 06:07:402026-07N213411-002ODE-3092027-04-17caaa826d4ba7…
2026-08-18 06:07:402026-07N213411-002ODE-4222030-01-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N213411-001I-9062026-01-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213411-001ODE-3092027-04-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213411-001ODE-4222030-01-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213411-002I-9062026-01-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213411-002ODE-3092027-04-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213411-002ODE-4222030-01-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213411-001NCE2025-04-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213411-001I-9062026-01-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213411-001ODE-3092027-04-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213411-001ODE-4222030-01-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213411-002NCE2025-04-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213411-002I-9062026-01-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213411-002ODE-3092027-04-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213411-002ODE-4222030-01-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08N213411-001NCE2025-04-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213411-001I-9062026-01-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213411-001ODE-3092027-04-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213411-001ODE-4222030-01-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213411-002NCE2025-04-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213411-002I-9062026-01-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213411-002ODE-3092027-04-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213411-002ODE-4222030-01-196a471c1ec25d…

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
TUKYSA
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TUCATINIB50 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
6fbd243a-23ac-4b83-835c-886425abd82fProduct name120200728
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51144-001-60TUKYSA60 in 1 BOTTLETABLET609

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51144-001-60EA - Each51144-001bb89daf3-319a-4aa2-b561-31f92891ee6b12020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51144-001TUKYSA (TUCATINIB) TABLET [SEAGEN INC.]9Current NDC, Legacy NDC, 1 package rows20241105_f27eb1b9-b7fc-424e-988f-84dd7bb195a3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2361290tucatinib 150 MG Oral TabletPSNf27eb1b9-b7fc-424e-988f-84dd7bb195a39
2361298tucatinib 50 MG Oral TabletPSNf27eb1b9-b7fc-424e-988f-84dd7bb195a39
2361296TUKYSA 150 MG Oral TabletPSNf27eb1b9-b7fc-424e-988f-84dd7bb195a39
2361300TUKYSA 50 MG Oral TabletPSNf27eb1b9-b7fc-424e-988f-84dd7bb195a39
2361296tucatinib 150 MG Oral Tablet [Tukysa]SBDf27eb1b9-b7fc-424e-988f-84dd7bb195a39
2361300tucatinib 50 MG Oral Tablet [Tukysa]SBDf27eb1b9-b7fc-424e-988f-84dd7bb195a39
2361290tucatinib 150 MG Oral TabletSCDf27eb1b9-b7fc-424e-988f-84dd7bb195a39
2361298tucatinib 50 MG Oral TabletSCDf27eb1b9-b7fc-424e-988f-84dd7bb195a39
2361296Tukysa 150 MG Oral TabletSYf27eb1b9-b7fc-424e-988f-84dd7bb195a39
2361300Tukysa 50 MG Oral TabletSYf27eb1b9-b7fc-424e-988f-84dd7bb195a39

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51144-001-605114400016060 TABLET in 1 BOTTLE (51144-001-60) 60 tablet2020-04-170000-00-00NoNoCurrent