FDA.reportPublic FDA data

TUKYSA

Product NDC
51144-001
11-digit product format
511440001
Labeler code
51144
Product ID
51144-001_892c322b-be43-4180-89f7-4e3619a8b58f
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
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 · 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 · 74 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2022-03-09 01:35 UTC2022-03N213411-001TUKYSA50MGTABLET / ORALRLD2020-04-17bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N213411-002TUKYSA150MGTABLET / ORALRLD, RS2020-04-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N213411-001TUKYSA50MGTABLET / ORALRLD2020-04-17782e0a99824c…
2021-12-28 21:50 UTC2021-12N213411-002TUKYSA150MGTABLET / ORALRLD, RS2020-04-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N213411-001TUKYSA50MGTABLET / ORALRLD2020-04-1787673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N213411-002TUKYSA150MGTABLET / ORALRLD, RS2020-04-1787673890dc5c…

Observed Orange Book patent history#

Patent history page 1 of 12 · 442 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N213411-00196939892027-05-09U-2788Drug product2020-04-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213411-00186480872031-04-12Drug substance, Drug product2020-04-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213411-00194570932032-10-12U-2788Drug product2020-04-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213411-001115043702033-03-25U-27882022-12-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213411-001112073242038-04-27U-37832023-02-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213411-001116665722038-04-27U-37832024-01-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213411-001120486982038-04-27U-37832024-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213411-00296939892027-05-09U-2788Drug product2020-04-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213411-00286480872031-04-12Drug substance, Drug product2020-04-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213411-00294570932032-10-12U-2788Drug product2020-04-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213411-002115043702033-03-25U-27882022-12-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213411-002112073242038-04-27U-37832023-02-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213411-002116665722038-04-27U-37832024-01-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213411-002120486982038-04-27U-37832024-08-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213411-00174528952025-11-16U-4153Drug substance, Drug product2020-04-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213411-00174528952025-11-16U-2788Drug substance, Drug product2020-04-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213411-00196939892027-05-09U-2788Drug product2020-04-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213411-00186480872031-04-12Drug substance, Drug product2020-04-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213411-00194570932032-10-12U-2788Drug product2020-04-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213411-001115043702033-03-25U-27882022-12-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213411-001112073242038-04-27U-37832023-02-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213411-001116665722038-04-27U-37832024-01-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213411-001120486982038-04-27U-37832024-08-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213411-00274528952025-11-16U-4153Drug substance, Drug product2020-04-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213411-00274528952025-11-16U-2788Drug substance, Drug product2020-04-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213411-00296939892027-05-09U-2788Drug product2020-04-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213411-00286480872031-04-12Drug substance, Drug product2020-04-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213411-00294570932032-10-12U-2788Drug product2020-04-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213411-002115043702033-03-25U-27882022-12-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213411-002112073242038-04-27U-37832023-02-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213411-002116665722038-04-27U-37832024-01-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213411-002120486982038-04-27U-37832024-08-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N213411-00174528952025-11-16U-4153Drug substance, Drug product2020-04-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213411-00174528952025-11-16U-2788Drug substance, Drug product2020-04-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213411-00196939892027-05-09U-2788Drug product2020-04-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213411-00186480872031-04-12Drug substance, Drug product2020-04-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213411-00194570932032-10-12U-2788Drug product2020-04-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213411-001115043702033-03-25U-27882022-12-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213411-001112073242038-04-27U-37832023-02-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213411-001116665722038-04-27U-37832024-01-296a471c1ec25d…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 6 · 236 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
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…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N213411-001NCE2025-04-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N213411-001I-9062026-01-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N213411-001ODE-3092027-04-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N213411-001ODE-4222030-01-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N213411-002NCE2025-04-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N213411-002I-9062026-01-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N213411-002ODE-3092027-04-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N213411-002ODE-4222030-01-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N213411-001NCE2025-04-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N213411-001I-9062026-01-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N213411-001ODE-3092027-04-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N213411-001ODE-4222030-01-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N213411-002NCE2025-04-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N213411-002I-9062026-01-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N213411-002ODE-3092027-04-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N213411-002ODE-4222030-01-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N213411-001NCE2025-04-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N213411-001I-9062026-01-1903ed91905a0d…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TUCATINIB50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
234248D0HHInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2361290Internal RxNorm lookup
2361296Internal RxNorm lookup
2361298Internal RxNorm lookup
2361300Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f27eb1b9-b7fc-424e-988f-84dd7bb195a3Available on FDA.report

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51144-001-602024-01-30C16284748780-11030e365-1a2f-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use TUKYSA safely and effectively. See full prescribing information for TUKYSA. TUKYSA ® (tucatinib) tablets, for oral use Initial U.S. Approval: 2020

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

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TUKYSATUCATINIBSEAGEN INC.f27eb1b9-b7fc-424e-988f-84dd7bb195a32024-11-04Warnings, Adverse reactionsExact identifier
application applno (NDA): 213411
application number: NDA213411
ndc (product): 51144-001

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