Home NDC 73150-200 UKONIQ
Product NDC 73150-200
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 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 2026-08-01 22:54:32 2026-06 N213176-001 UKONIQ EQ 200MG BASE TABLET / ORAL RLD 2021-02-05 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-01 22:54:32 2026-06 N213176-001 10072013 2033-07-02 U-3063 2021-02-17 a50c72e98297…2026-08-01 22:54:32 2026-06 N213176-001 10072013 2033-07-02 U-3064 2021-02-17 a50c72e98297…2026-08-01 22:54:32 2026-06 N213176-001 10570142 2033-07-02 U-3064 Drug substance, Drug product 2021-02-17 a50c72e98297…2026-08-01 22:54:32 2026-06 N213176-001 10570142 2033-07-02 U-3063 Drug substance, Drug product 2021-02-17 a50c72e98297…2026-08-01 22:54:32 2026-06 N213176-001 10981919 2033-07-02 U-3063 2022-02-04 a50c72e98297…2026-08-01 22:54:32 2026-06 N213176-001 10981919 2033-07-02 U-3064 2022-02-04 a50c72e98297…2026-08-01 22:54:32 2026-06 N213176-001 9150579 2033-07-02 Drug substance, Drug product 2021-02-17 a50c72e98297…2026-08-01 22:54:32 2026-06 N213176-001 9669033 2033-07-02 U-3063 2021-02-17 a50c72e98297…2026-08-01 22:54:32 2026-06 N213176-001 9669033 2033-07-02 U-3064 2021-02-17 a50c72e98297…2026-08-01 22:54:32 2026-06 N213176-001 10414773 2035-05-26 U-3063 Drug substance, Drug product 2021-02-17 a50c72e98297…2026-08-01 22:54:32 2026-06 N213176-001 10414773 2035-05-26 U-3064 Drug substance, Drug product 2021-02-17 a50c72e98297…2026-08-01 22:54:32 2026-06 N213176-001 10947244 2035-05-26 U-3063 2021-04-07 a50c72e98297…2026-08-01 22:54:32 2026-06 N213176-001 10947244 2035-05-26 U-3064 2021-04-07 a50c72e98297…2026-08-01 22:54:32 2026-06 N213176-001 9969740 2035-05-26 U-3064 Drug substance, Drug product 2021-02-17 a50c72e98297…2026-08-01 22:54:32 2026-06 N213176-001 9969740 2035-05-26 U-3063 Drug substance, Drug product 2021-02-17 a50c72e98297…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-08-01 22:54:32 2026-06 N213176-001 NCE 2026-02-05 a50c72e98297…
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 0000-00-00 No No Current