Home NDC 73150-200-12 UKONIQ
Product NDC 73150-200
Requested package NDC 73150-200-12
11-digit product format 731500200
Labeler code 73150
Product ID 73150-200_efea3e7e-8e4a-85d4-e053-2a95a90a6e3a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name umbralisib
Dosage form TABLET, FILM COATED
Route ORAL
Labeler TG Therapeutics, Inc.
Application NDA213176
Marketing category NDA
Marketing start 2021-02-05
Marketing end 2023-07-31
Substance UMBRALISIB TOSYLATE
Active strength 260 mg/1
Pharmacologic classes Kinase Inhibitor [EPC], Kinase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.
Historic NDC status page 1 of 1 · 12 matching rows.
Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 73150-200 73150-200-12 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 73150-200 73150-200-12 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 73150-200 73150-200-12 D Discontinued by firm excluded / ndc_excluded.zip 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 73150-200 73150-200-12 D Discontinued by firm excluded / ndc_excluded.zip a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 73150-200 73150-200-12 D Discontinued by firm excluded / ndc_excluded.zip cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 73150-200 73150-200-12 D Discontinued by firm excluded / ndc_excluded.zip cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 73150-200 73150-200-12 D Discontinued by firm excluded / ndc_excluded.zip 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 73150-200 73150-200-12 D Discontinued by firm excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 73150-200 73150-200-12 D Discontinued by firm excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 73150-200 73150-200-12 D Discontinued by firm excluded / ndc_excluded.zip ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 73150-200 73150-200-12 D Discontinued by firm excluded / ndc_excluded.zip 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 73150-200 73150-200-12 D Discontinued by firm excluded / ndc_excluded.zip 557ba5c1ecfa…9c80585c8c6e…
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 N213176-001 UKONIQ UMBRALISIB TOSYLATE EQ 200MG BASE TABLET / ORAL RLD 2021-02-05
Orange Book patents# Current patent rows page 1 of 1 · 15 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N213176-001 10072013 2033-07-02 U-3063 2021-02-17 N213176-001 10072013 2033-07-02 U-3064 2021-02-17 N213176-001 10570142 2033-07-02 U-3063 Drug substance, Drug product 2021-02-17 N213176-001 10570142 2033-07-02 U-3064 Drug substance, Drug product 2021-02-17 N213176-001 10981919 2033-07-02 U-3063 2022-02-04 N213176-001 10981919 2033-07-02 U-3064 2022-02-04 N213176-001 9150579 2033-07-02 Drug substance, Drug product 2021-02-17 N213176-001 9669033 2033-07-02 U-3063 2021-02-17 N213176-001 9669033 2033-07-02 U-3064 2021-02-17 N213176-001 10414773 2035-05-26 U-3063 Drug substance, Drug product 2021-02-17 N213176-001 10414773 2035-05-26 U-3064 Drug substance, Drug product 2021-02-17 N213176-001 10947244 2035-05-26 U-3063 2021-04-07 N213176-001 10947244 2035-05-26 U-3064 2021-04-07 N213176-001 9969740 2035-05-26 U-3063 Drug substance, Drug product 2021-02-17 N213176-001 9969740 2035-05-26 U-3064 Drug substance, Drug product 2021-02-17
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N213176-001 NCE 2026-02-05
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.
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 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD 2021-02-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD 2021-02-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD 2021-02-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD 2021-02-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD 2021-02-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD 2021-02-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD 2021-02-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD 2021-02-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD 2021-02-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD 2021-02-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD 2021-02-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD 2021-02-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD 2021-02-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD 2021-02-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD 2021-02-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD, RS 2021-02-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD, RS 2021-02-05 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD, RS 2021-02-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD, RS 2021-02-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD, RS 2021-02-05 87673890dc5c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD 2021-02-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD 2021-02-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD 2021-02-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD 2021-02-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD 2021-02-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD 2021-02-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD 2021-02-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD 2021-02-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD 2021-02-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD 2021-02-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD 2021-02-05 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD 2021-02-05 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD 2021-02-05 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD 2021-02-05 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 13 · 506 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 N213176-001 10072013 2033-07-02 U-3063 2021-02-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213176-001 10072013 2033-07-02 U-3064 2021-02-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213176-001 10570142 2033-07-02 U-3064 Drug substance, Drug product 2021-02-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213176-001 10570142 2033-07-02 U-3063 Drug substance, Drug product 2021-02-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213176-001 10981919 2033-07-02 U-3063 2022-02-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213176-001 10981919 2033-07-02 U-3064 2022-02-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213176-001 9150579 2033-07-02 Drug substance, Drug product 2021-02-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213176-001 9669033 2033-07-02 U-3063 2021-02-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213176-001 9669033 2033-07-02 U-3064 2021-02-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213176-001 10414773 2035-05-26 U-3063 Drug substance, Drug product 2021-02-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213176-001 10414773 2035-05-26 U-3064 Drug substance, Drug product 2021-02-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213176-001 10947244 2035-05-26 U-3063 2021-04-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213176-001 10947244 2035-05-26 U-3064 2021-04-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213176-001 9969740 2035-05-26 U-3064 Drug substance, Drug product 2021-02-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213176-001 9969740 2035-05-26 U-3063 Drug substance, Drug product 2021-02-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213176-001 10072013 2033-07-02 U-3063 2021-02-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213176-001 10072013 2033-07-02 U-3064 2021-02-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213176-001 10570142 2033-07-02 U-3064 Drug substance, Drug product 2021-02-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213176-001 10570142 2033-07-02 U-3063 Drug substance, Drug product 2021-02-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213176-001 10981919 2033-07-02 U-3063 2022-02-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213176-001 10981919 2033-07-02 U-3064 2022-02-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213176-001 9150579 2033-07-02 Drug substance, Drug product 2021-02-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213176-001 9669033 2033-07-02 U-3063 2021-02-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213176-001 9669033 2033-07-02 U-3064 2021-02-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213176-001 10414773 2035-05-26 U-3063 Drug substance, Drug product 2021-02-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213176-001 10414773 2035-05-26 U-3064 Drug substance, Drug product 2021-02-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213176-001 10947244 2035-05-26 U-3063 2021-04-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213176-001 10947244 2035-05-26 U-3064 2021-04-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213176-001 9969740 2035-05-26 U-3064 Drug substance, Drug product 2021-02-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213176-001 9969740 2035-05-26 U-3063 Drug substance, Drug product 2021-02-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213176-001 10072013 2033-07-02 U-3063 2021-02-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213176-001 10072013 2033-07-02 U-3064 2021-02-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213176-001 10570142 2033-07-02 U-3064 Drug substance, Drug product 2021-02-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213176-001 10570142 2033-07-02 U-3063 Drug substance, Drug product 2021-02-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213176-001 10981919 2033-07-02 U-3063 2022-02-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213176-001 10981919 2033-07-02 U-3064 2022-02-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213176-001 9150579 2033-07-02 Drug substance, Drug product 2021-02-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213176-001 9669033 2033-07-02 U-3063 2021-02-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213176-001 9669033 2033-07-02 U-3064 2021-02-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213176-001 10414773 2035-05-26 U-3063 Drug substance, Drug product 2021-02-17 6a471c1ec25d…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 46 observed states.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 73150-200-12 73150020012 4 CARTON in 1 CASE (73150-200-12) > 12 BOTTLE, PLASTIC in 1 CARTON > 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 4 carton 2021-02-05 2023-07-31 No No Current