Home NDC 71274-170 Joenja
Product NDC 71274-170
11-digit product format 712740170
Labeler code 71274
Product ID 71274-170_b95f3490-8e01-42bf-85a6-61c5876a31c8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Leniolisib
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Pharming Healthcare Inc.
Application NDA217759
Marketing category NDA
Marketing start 2023-03-29
Substance LENIOLISIB PHOSPHATE
Active strength 70 mg/1
Pharmacologic classes Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inhibitors [MoA], Kinase Inhibitor [EPC], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA], Phosphoinositide 3-Kinase delta 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 43 .
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 N217759-001 JOENJA LENIOLISIB PHOSPHATE EQ 70MG BASE TABLET / ORAL RLD, RS 2023-03-24
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N217759-001 8653092 2032-02-19 Drug substance, Drug product 2023-04-18
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N217759-001 NCE 2028-03-24 N217759-001 ODE-430 2030-03-24
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 2026-09-14 22:38:34 2026-08 N217759-001 JOENJA EQ 70MG BASE TABLET / ORAL RLD, RS 2023-03-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 N217759-001 JOENJA EQ 70MG BASE TABLET / ORAL RLD, RS 2023-03-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N217759-001 JOENJA EQ 70MG BASE TABLET / ORAL RLD, RS 2023-03-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217759-001 JOENJA EQ 70MG BASE TABLET / ORAL RLD, RS 2023-03-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217759-001 JOENJA EQ 70MG BASE TABLET / ORAL RLD, RS 2023-03-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217759-001 JOENJA EQ 70MG BASE TABLET / ORAL RLD, RS 2023-03-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217759-001 JOENJA EQ 70MG BASE TABLET / ORAL RLD, RS 2023-03-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217759-001 JOENJA EQ 70MG BASE TABLET / ORAL RLD, RS 2023-03-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217759-001 JOENJA EQ 70MG BASE TABLET / ORAL RLD, RS 2023-03-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217759-001 JOENJA EQ 70MG BASE TABLET / ORAL RLD, RS 2023-03-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217759-001 JOENJA EQ 70MG BASE TABLET / ORAL RLD, RS 2023-03-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N217759-001 JOENJA EQ 70MG BASE TABLET / ORAL RLD, RS 2023-03-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N217759-001 JOENJA EQ 70MG BASE TABLET / ORAL RLD, RS 2023-03-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N217759-001 JOENJA EQ 70MG BASE TABLET / ORAL RLD, RS 2023-03-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N217759-001 JOENJA EQ 70MG BASE TABLET / ORAL RLD, RS 2023-03-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N217759-001 JOENJA EQ 70MG BASE TABLET / ORAL RLD, RS 2023-03-24 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N217759-001 JOENJA EQ 70MG BASE TABLET / ORAL RLD, RS 2023-03-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N217759-001 JOENJA EQ 70MG BASE TABLET / ORAL RLD, RS 2023-03-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N217759-001 JOENJA EQ 70MG BASE TABLET / ORAL RLD, RS 2023-03-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N217759-001 JOENJA EQ 70MG BASE TABLET / ORAL RLD, RS 2023-03-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N217759-001 JOENJA EQ 70MG BASE TABLET / ORAL RLD, RS 2023-03-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N217759-001 JOENJA EQ 70MG BASE TABLET / ORAL RLD, RS 2023-03-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N217759-001 JOENJA EQ 70MG BASE TABLET / ORAL RLD, RS 2023-03-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N217759-001 JOENJA EQ 70MG BASE TABLET / ORAL RLD, RS 2023-03-24 053a50430f4f…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217759-001 JOENJA EQ 70MG BASE TABLET / ORAL RLD, RS 2023-03-24 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 2026-09-14 22:38:34 2026-08 N217759-001 8653092 2032-02-19 Drug substance, Drug product 2023-04-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 N217759-001 8653092 2032-02-19 Drug substance, Drug product 2023-04-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N217759-001 8653092 2032-02-19 Drug substance, Drug product 2023-04-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217759-001 8653092 2032-02-19 Drug substance, Drug product 2023-04-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217759-001 8653092 2032-02-19 Drug substance, Drug product 2023-04-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217759-001 8653092 2032-02-19 Drug substance, Drug product 2023-04-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217759-001 8653092 2032-02-19 Drug substance, Drug product 2023-04-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217759-001 8653092 2032-02-19 Drug substance, Drug product 2023-04-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217759-001 8653092 2032-02-19 Drug substance, Drug product 2023-04-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217759-001 8653092 2032-02-19 Drug substance, Drug product 2023-04-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217759-001 8653092 2032-02-19 Drug substance, Drug product 2023-04-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N217759-001 8653092 2032-02-19 Drug substance, Drug product 2023-04-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N217759-001 8653092 2032-02-19 Drug substance, Drug product 2023-04-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N217759-001 8653092 2032-02-19 Drug substance, Drug product 2023-04-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N217759-001 8653092 2032-02-19 Drug substance, Drug product 2023-04-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N217759-001 8653092 2032-02-19 Drug substance, Drug product 2023-04-18 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N217759-001 8653092 2032-02-19 Drug substance, Drug product 2023-04-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N217759-001 8653092 2032-02-19 Drug substance, Drug product 2023-04-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N217759-001 8653092 2032-02-19 Drug substance, Drug product 2023-04-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N217759-001 8653092 2032-02-19 Drug substance, Drug product 2023-04-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N217759-001 8653092 2032-02-19 Drug substance, Drug product 2023-04-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N217759-001 8653092 2032-02-19 Drug substance, Drug product 2023-04-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N217759-001 8653092 2032-02-19 Drug substance, Drug product 2023-04-18 3f0d92c62455…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217759-001 8653092 2032-02-19 Drug substance, Drug product 2023-04-18 a50c72e98297…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 48 observed states.
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 Joenja
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LENIOLISIB PHOSPHATE 70 mg/1
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71274-170-60 Joenja 60 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 60 6 71274-170-60 Joenja 1 in 1 CARTON TABLET, FILM COATED 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71274-170 JOENJA (LENIOLISIB) TABLET, FILM COATED [PHARMING HEALTHCARE INC.] 5 Current NDC, 2 package rows 20231006_eefbcef8-2130-4654-8f29-b58077e08212.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 71274-170-60 71274017060 1 BOTTLE, PLASTIC in 1 CARTON (71274-170-60) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2023-03-29 No No Current