Home DailyMed bfb0eea0-71fc-4d87-960a-ee196dbf52cd National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2012-07-24
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 02:35:42 Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022068-001 TASIGNA NILOTINIB HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL AB RLD, RS 2007-10-29 N022068-002 TASIGNA NILOTINIB HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB RLD 2010-06-17 N022068-003 TASIGNA NILOTINIB HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB RLD 2018-03-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 42 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022068-001 8389537 2026-07-18 U-1374 2013-03-29 N022068-001 8415363 2026-07-18 U-1374 Drug substance, Drug product 2013-06-13 N022068-001 8415363 2026-07-18 U-1407 Drug substance, Drug product 2013-06-13 N022068-001 8501760 2026-07-18 Drug product 2013-08-09 N022068-001 8389537*PED 2027-01-18 Pediatric extension N022068-001 8415363*PED 2027-01-18 Pediatric extension N022068-001 8501760*PED 2027-01-18 Pediatric extension N022068-001 8293756 2027-09-25 Drug product 2014-10-08 N022068-001 8293756*PED 2028-03-25 Pediatric extension N022068-001 8163904 2028-08-23 Drug substance, Drug product 2012-05-10 N022068-001 8163904*PED 2029-02-23 Pediatric extension N022068-001 9061029 2032-04-07 U-1374 Drug substance 2016-12-01 N022068-001 9061029 2032-04-07 U-3231 Drug substance 2016-12-01 N022068-001 9061029*PED 2032-10-07 Pediatric extension N022068-002 8389537 2026-07-18 U-1374 N022068-002 8415363 2026-07-18 U-1374 Drug substance, Drug product N022068-002 8415363 2026-07-18 U-1407 Drug substance, Drug product N022068-002 8501760 2026-07-18 Drug product 2013-08-09 N022068-002 8389537*PED 2027-01-18 Pediatric extension N022068-002 8415363*PED 2027-01-18 Pediatric extension N022068-002 8501760*PED 2027-01-18 Pediatric extension N022068-002 8293756 2027-09-25 Drug product 2014-10-08 N022068-002 8293756*PED 2028-03-25 Pediatric extension N022068-002 8163904 2028-08-23 Drug substance, Drug product N022068-002 8163904*PED 2029-02-23 Pediatric extension N022068-002 9061029 2032-04-07 U-1374 Drug substance 2016-12-01 N022068-002 9061029 2032-04-07 U-3231 Drug substance 2016-12-01 N022068-002 9061029*PED 2032-10-07 Pediatric extension N022068-003 8389537 2026-07-18 U-1374 2018-04-12 N022068-003 8415363 2026-07-18 U-1374 Drug substance, Drug product 2018-04-12 N022068-003 8415363 2026-07-18 U-1407 Drug substance, Drug product 2018-04-12 N022068-003 8501760 2026-07-18 Drug product 2018-04-12 N022068-003 8389537*PED 2027-01-18 Pediatric extension N022068-003 8415363*PED 2027-01-18 Pediatric extension N022068-003 8501760*PED 2027-01-18 Pediatric extension N022068-003 8293756 2027-09-25 Drug product 2018-04-12 N022068-003 8293756*PED 2028-03-25 Pediatric extension N022068-003 8163904 2028-08-23 Drug substance, Drug product 2018-04-12 N022068-003 8163904*PED 2029-02-23 Pediatric extension N022068-003 9061029 2032-04-07 U-1374 Drug substance 2018-04-12 N022068-003 9061029 2032-04-07 U-3231 Drug substance 2018-04-12 N022068-003 9061029*PED 2032-10-07 Pediatric extension
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 6 matching rows.
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 4 · 129 observed 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 N022068-001 TASIGNA EQ 200MG BASE CAPSULE / ORAL AB RLD, RS 2007-10-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022068-002 TASIGNA EQ 150MG BASE CAPSULE / ORAL AB RLD 2010-06-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022068-003 TASIGNA EQ 50MG BASE CAPSULE / ORAL AB RLD 2018-03-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022068-001 TASIGNA EQ 200MG BASE CAPSULE / ORAL AB RLD, RS 2007-10-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022068-002 TASIGNA EQ 150MG BASE CAPSULE / ORAL AB RLD 2010-06-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022068-003 TASIGNA EQ 50MG BASE CAPSULE / ORAL AB RLD 2018-03-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022068-001 TASIGNA EQ 200MG BASE CAPSULE / ORAL AB RLD, RS 2007-10-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022068-002 TASIGNA EQ 150MG BASE CAPSULE / ORAL AB RLD 2010-06-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022068-003 TASIGNA EQ 50MG BASE CAPSULE / ORAL AB RLD 2018-03-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022068-001 TASIGNA EQ 200MG BASE CAPSULE / ORAL AB RLD, RS 2007-10-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022068-002 TASIGNA EQ 150MG BASE CAPSULE / ORAL AB RLD 2010-06-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022068-003 TASIGNA EQ 50MG BASE CAPSULE / ORAL AB RLD 2018-03-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022068-001 TASIGNA EQ 200MG BASE CAPSULE / ORAL AB RLD, RS 2007-10-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022068-002 TASIGNA EQ 150MG BASE CAPSULE / ORAL AB RLD 2010-06-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022068-003 TASIGNA EQ 50MG BASE CAPSULE / ORAL AB RLD 2018-03-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022068-001 TASIGNA EQ 200MG BASE CAPSULE / ORAL RLD, RS 2007-10-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022068-002 TASIGNA EQ 150MG BASE CAPSULE / ORAL RLD 2010-06-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022068-003 TASIGNA EQ 50MG BASE CAPSULE / ORAL RLD 2018-03-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022068-001 TASIGNA EQ 200MG BASE CAPSULE / ORAL RLD, RS 2007-10-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022068-002 TASIGNA EQ 150MG BASE CAPSULE / ORAL RLD 2010-06-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022068-003 TASIGNA EQ 50MG BASE CAPSULE / ORAL RLD 2018-03-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022068-001 TASIGNA EQ 200MG BASE CAPSULE / ORAL RLD, RS 2007-10-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022068-002 TASIGNA EQ 150MG BASE CAPSULE / ORAL RLD 2010-06-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022068-003 TASIGNA EQ 50MG BASE CAPSULE / ORAL RLD 2018-03-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022068-001 TASIGNA EQ 200MG BASE CAPSULE / ORAL RLD, RS 2007-10-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022068-002 TASIGNA EQ 150MG BASE CAPSULE / ORAL RLD 2010-06-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022068-003 TASIGNA EQ 50MG BASE CAPSULE / ORAL RLD 2018-03-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022068-001 TASIGNA EQ 200MG BASE CAPSULE / ORAL RLD, RS 2007-10-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022068-002 TASIGNA EQ 150MG BASE CAPSULE / ORAL RLD 2010-06-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022068-003 TASIGNA EQ 50MG BASE CAPSULE / ORAL RLD 2018-03-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022068-001 TASIGNA EQ 200MG BASE CAPSULE / ORAL RLD, RS 2007-10-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022068-002 TASIGNA EQ 150MG BASE CAPSULE / ORAL RLD 2010-06-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022068-003 TASIGNA EQ 50MG BASE CAPSULE / ORAL RLD 2018-03-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022068-001 TASIGNA EQ 200MG BASE CAPSULE / ORAL RLD, RS 2007-10-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022068-002 TASIGNA EQ 150MG BASE CAPSULE / ORAL RLD 2010-06-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022068-003 TASIGNA EQ 50MG BASE CAPSULE / ORAL RLD 2018-03-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022068-001 TASIGNA EQ 200MG BASE CAPSULE / ORAL RLD, RS 2007-10-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022068-002 TASIGNA EQ 150MG BASE CAPSULE / ORAL RLD 2010-06-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022068-003 TASIGNA EQ 50MG BASE CAPSULE / ORAL RLD 2018-03-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022068-001 TASIGNA EQ 200MG BASE CAPSULE / ORAL RLD, RS 2007-10-29 301d65b070ca…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 49 · 1,935 observed states.
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 N022068-001 8389537 2026-07-18 U-1374 2013-03-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022068-001 8415363 2026-07-18 U-1407 Drug substance, Drug product 2013-06-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022068-001 8415363 2026-07-18 U-1374 Drug substance, Drug product 2013-06-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022068-001 8501760 2026-07-18 Drug product 2013-08-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022068-001 8389537*PED 2027-01-18 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022068-001 8415363*PED 2027-01-18 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022068-001 8501760*PED 2027-01-18 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022068-001 8293756 2027-09-25 Drug product 2014-10-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022068-001 8293756*PED 2028-03-25 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022068-001 8163904 2028-08-23 Drug substance, Drug product 2012-05-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022068-001 8163904*PED 2029-02-23 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022068-001 9061029 2032-04-07 U-1374 Drug substance 2016-12-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022068-001 9061029 2032-04-07 U-3231 Drug substance 2016-12-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022068-001 9061029*PED 2032-10-07 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022068-002 8389537 2026-07-18 U-1374 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022068-002 8415363 2026-07-18 U-1407 Drug substance, Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022068-002 8415363 2026-07-18 U-1374 Drug substance, Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022068-002 8501760 2026-07-18 Drug product 2013-08-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022068-002 8389537*PED 2027-01-18 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022068-002 8415363*PED 2027-01-18 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022068-002 8501760*PED 2027-01-18 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022068-002 8293756 2027-09-25 Drug product 2014-10-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022068-002 8293756*PED 2028-03-25 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022068-002 8163904 2028-08-23 Drug substance, Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022068-002 8163904*PED 2029-02-23 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022068-002 9061029 2032-04-07 U-1374 Drug substance 2016-12-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022068-002 9061029 2032-04-07 U-3231 Drug substance 2016-12-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022068-002 9061029*PED 2032-10-07 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022068-003 8389537 2026-07-18 U-1374 2018-04-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022068-003 8415363 2026-07-18 U-1407 Drug substance, Drug product 2018-04-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022068-003 8415363 2026-07-18 U-1374 Drug substance, Drug product 2018-04-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022068-003 8501760 2026-07-18 Drug product 2018-04-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022068-003 8389537*PED 2027-01-18 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022068-003 8415363*PED 2027-01-18 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022068-003 8501760*PED 2027-01-18 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022068-003 8293756 2027-09-25 Drug product 2018-04-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022068-003 8293756*PED 2028-03-25 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022068-003 8163904 2028-08-23 Drug substance, Drug product 2018-04-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022068-003 8163904*PED 2029-02-23 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022068-003 9061029 2032-04-07 U-1374 Drug substance 2018-04-12 84e616aacf4f…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 19 · 756 observed states.
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.