Home DailyMed e4c2c9c2-9c38-4559-8d5f-33267bf01f40 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 2013-02-13
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 03:24:55 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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N203469-001 ICLUSIG PONATINIB HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL RLD 2012-12-14 N203469-002 ICLUSIG PONATINIB HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL RLD 2012-12-14 N203469-003 ICLUSIG PONATINIB HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL RLD 2015-04-23 N203469-004 ICLUSIG PONATINIB HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL RLD, RS 2020-12-18
Orange Book patents# Current patent rows page 1 of 1 · 68 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N203469-001 9029533 2026-12-22 U-1283 2015-06-09 N203469-001 9029533 2026-12-22 U-1699 2015-06-09 N203469-001 9029533 2026-12-22 U-1700 2015-06-09 N203469-001 9029533 2026-12-22 U-1701 2015-06-09 N203469-001 9029533 2026-12-22 U-836 2015-06-09 N203469-001 8114874 2027-01-24 Drug substance, Drug product N203469-001 11192895 2033-12-12 U-1700 2022-01-06 N203469-001 11192895 2033-12-12 U-1701 2022-01-06 N203469-001 11192895 2033-12-12 U-1948 2022-01-06 N203469-001 11192897 2033-12-12 U-1700 Drug substance 2022-01-06 N203469-001 11192897 2033-12-12 U-1701 Drug substance 2022-01-06 N203469-001 11192897 2033-12-12 U-1948 Drug substance 2022-01-06 N203469-001 11384086 2033-12-12 U-1700 Drug substance, Drug product 2022-08-03 N203469-001 11384086 2033-12-12 U-1701 Drug substance, Drug product 2022-08-03 N203469-001 11384086 2033-12-12 U-1948 Drug substance, Drug product 2022-08-03 N203469-001 9493470 2033-12-12 U-1700 Drug substance, Drug product 2016-11-29 N203469-001 9493470 2033-12-12 U-1948 Drug substance, Drug product 2016-11-29 N203469-002 9029533 2026-12-22 U-1283 2015-06-09 N203469-002 9029533 2026-12-22 U-1699 2015-06-09 N203469-002 9029533 2026-12-22 U-1700 2015-06-09 N203469-002 9029533 2026-12-22 U-1701 2015-06-09 N203469-002 9029533 2026-12-22 U-836 2015-06-09 N203469-002 8114874 2027-01-24 Drug substance, Drug product N203469-002 11192895 2033-12-12 U-1700 2022-01-06 N203469-002 11192895 2033-12-12 U-1701 2022-01-06 N203469-002 11192895 2033-12-12 U-1948 2022-01-06 N203469-002 11192897 2033-12-12 U-1700 Drug substance 2022-01-06 N203469-002 11192897 2033-12-12 U-1701 Drug substance 2022-01-06 N203469-002 11192897 2033-12-12 U-1948 Drug substance 2022-01-06 N203469-002 11384086 2033-12-12 U-1700 Drug substance, Drug product 2022-08-03 N203469-002 11384086 2033-12-12 U-1701 Drug substance, Drug product 2022-08-03 N203469-002 11384086 2033-12-12 U-1948 Drug substance, Drug product 2022-08-03 N203469-002 9493470 2033-12-12 U-1700 Drug substance, Drug product 2016-11-29 N203469-002 9493470 2033-12-12 U-1948 Drug substance, Drug product 2016-11-29 N203469-003 9029533 2026-12-22 U-1283 2015-06-09 N203469-003 9029533 2026-12-22 U-1699 2015-06-09 N203469-003 9029533 2026-12-22 U-1700 2015-06-09 N203469-003 9029533 2026-12-22 U-1701 2015-06-09 N203469-003 9029533 2026-12-22 U-836 2015-06-09 N203469-003 8114874 2027-01-24 Drug substance, Drug product 2015-06-09 N203469-003 11192895 2033-12-12 U-1700 2022-01-06 N203469-003 11192895 2033-12-12 U-1701 2022-01-06 N203469-003 11192895 2033-12-12 U-1948 2022-01-06 N203469-003 11192897 2033-12-12 U-1700 Drug substance 2022-01-06 N203469-003 11192897 2033-12-12 U-1701 Drug substance 2022-01-06 N203469-003 11192897 2033-12-12 U-1948 Drug substance 2022-01-06 N203469-003 11384086 2033-12-12 U-1700 Drug substance, Drug product 2022-08-03 N203469-003 11384086 2033-12-12 U-1701 Drug substance, Drug product 2022-08-03 N203469-003 11384086 2033-12-12 U-1948 Drug substance, Drug product 2022-08-03 N203469-003 9493470 2033-12-12 U-1700 Drug substance, Drug product 2016-11-29 N203469-003 9493470 2033-12-12 U-1948 Drug substance, Drug product 2016-11-29 N203469-004 9029533 2026-12-22 U-1283 2021-01-14 N203469-004 9029533 2026-12-22 U-1699 2021-01-14 N203469-004 9029533 2026-12-22 U-1700 2021-01-14 N203469-004 9029533 2026-12-22 U-1701 2021-01-14 N203469-004 9029533 2026-12-22 U-836 2021-01-14 N203469-004 8114874 2027-01-24 Drug substance, Drug product 2021-01-14 N203469-004 11192895 2033-12-12 U-1700 2022-01-06 N203469-004 11192895 2033-12-12 U-1701 2022-01-06 N203469-004 11192895 2033-12-12 U-1948 2022-01-06 N203469-004 11192897 2033-12-12 U-1700 Drug substance 2022-01-06 N203469-004 11192897 2033-12-12 U-1701 Drug substance 2022-01-06 N203469-004 11192897 2033-12-12 U-1948 Drug substance 2022-01-06 N203469-004 11384086 2033-12-12 U-1700 Drug substance, Drug product 2022-08-03 N203469-004 11384086 2033-12-12 U-1701 Drug substance, Drug product 2022-08-03 N203469-004 11384086 2033-12-12 U-1948 Drug substance, Drug product 2022-08-03 N203469-004 9493470 2033-12-12 U-1700 Drug substance, Drug product 2021-01-14 N203469-004 9493470 2033-12-12 U-1948 Drug substance, Drug product 2021-01-14
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 8 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 5 · 166 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 N203469-001 ICLUSIG EQ 15MG BASE TABLET / ORAL RLD 2012-12-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203469-002 ICLUSIG EQ 45MG BASE TABLET / ORAL RLD 2012-12-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203469-003 ICLUSIG EQ 30MG BASE TABLET / ORAL RLD 2015-04-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203469-004 ICLUSIG EQ 10MG BASE TABLET / ORAL RLD, RS 2020-12-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 N203469-001 ICLUSIG EQ 15MG BASE TABLET / ORAL RLD 2012-12-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203469-002 ICLUSIG EQ 45MG BASE TABLET / ORAL RLD 2012-12-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203469-003 ICLUSIG EQ 30MG BASE TABLET / ORAL RLD 2015-04-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203469-004 ICLUSIG EQ 10MG BASE TABLET / ORAL RLD, RS 2020-12-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N203469-001 ICLUSIG EQ 15MG BASE TABLET / ORAL RLD 2012-12-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203469-002 ICLUSIG EQ 45MG BASE TABLET / ORAL RLD 2012-12-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203469-003 ICLUSIG EQ 30MG BASE TABLET / ORAL RLD 2015-04-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203469-004 ICLUSIG EQ 10MG BASE TABLET / ORAL RLD, RS 2020-12-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203469-001 ICLUSIG EQ 15MG BASE TABLET / ORAL RLD 2012-12-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203469-002 ICLUSIG EQ 45MG BASE TABLET / ORAL RLD, RS 2012-12-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203469-003 ICLUSIG EQ 30MG BASE TABLET / ORAL RLD 2015-04-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203469-004 ICLUSIG EQ 10MG BASE TABLET / ORAL RLD 2020-12-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203469-001 ICLUSIG EQ 15MG BASE TABLET / ORAL RLD 2012-12-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203469-002 ICLUSIG EQ 45MG BASE TABLET / ORAL RLD, RS 2012-12-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203469-003 ICLUSIG EQ 30MG BASE TABLET / ORAL RLD 2015-04-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203469-004 ICLUSIG EQ 10MG BASE TABLET / ORAL RLD 2020-12-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203469-001 ICLUSIG EQ 15MG BASE TABLET / ORAL RLD 2012-12-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203469-002 ICLUSIG EQ 45MG BASE TABLET / ORAL RLD, RS 2012-12-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203469-003 ICLUSIG EQ 30MG BASE TABLET / ORAL RLD 2015-04-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203469-004 ICLUSIG EQ 10MG BASE TABLET / ORAL RLD 2020-12-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203469-001 ICLUSIG EQ 15MG BASE TABLET / ORAL RLD 2012-12-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203469-002 ICLUSIG EQ 45MG BASE TABLET / ORAL RLD, RS 2012-12-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203469-003 ICLUSIG EQ 30MG BASE TABLET / ORAL RLD 2015-04-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203469-004 ICLUSIG EQ 10MG BASE TABLET / ORAL RLD 2020-12-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203469-001 ICLUSIG EQ 15MG BASE TABLET / ORAL RLD 2012-12-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203469-002 ICLUSIG EQ 45MG BASE TABLET / ORAL RLD, RS 2012-12-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203469-003 ICLUSIG EQ 30MG BASE TABLET / ORAL RLD 2015-04-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203469-004 ICLUSIG EQ 10MG BASE TABLET / ORAL RLD 2020-12-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203469-001 ICLUSIG EQ 15MG BASE TABLET / ORAL RLD 2012-12-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203469-002 ICLUSIG EQ 45MG BASE TABLET / ORAL RLD, RS 2012-12-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203469-003 ICLUSIG EQ 30MG BASE TABLET / ORAL RLD 2015-04-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203469-004 ICLUSIG EQ 10MG BASE TABLET / ORAL RLD 2020-12-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203469-001 ICLUSIG EQ 15MG BASE TABLET / ORAL RLD 2012-12-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203469-002 ICLUSIG EQ 45MG BASE TABLET / ORAL RLD, RS 2012-12-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203469-003 ICLUSIG EQ 30MG BASE TABLET / ORAL RLD 2015-04-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203469-004 ICLUSIG EQ 10MG BASE TABLET / ORAL RLD 2020-12-18 5bbf6a4d5a75…
Observed Orange Book patent history# Patent history page 1 of 63 · 2,492 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 N203469-001 9029533 2026-12-22 U-1700 2015-06-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203469-001 9029533 2026-12-22 U-836 2015-06-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203469-001 9029533 2026-12-22 U-1701 2015-06-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203469-001 9029533 2026-12-22 U-1699 2015-06-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203469-001 9029533 2026-12-22 U-1283 2015-06-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203469-001 8114874 2027-01-24 Drug substance, Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203469-001 11192895 2033-12-12 U-1700 2022-01-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203469-001 11192895 2033-12-12 U-1701 2022-01-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203469-001 11192895 2033-12-12 U-1948 2022-01-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203469-001 11192897 2033-12-12 U-1700 Drug substance 2022-01-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203469-001 11192897 2033-12-12 U-1701 Drug substance 2022-01-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203469-001 11192897 2033-12-12 U-1948 Drug substance 2022-01-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203469-001 11384086 2033-12-12 U-1700 Drug substance, Drug product 2022-08-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203469-001 11384086 2033-12-12 U-1948 Drug substance, Drug product 2022-08-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203469-001 11384086 2033-12-12 U-1701 Drug substance, Drug product 2022-08-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203469-001 9493470 2033-12-12 U-1700 Drug substance, Drug product 2016-11-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203469-001 9493470 2033-12-12 U-1948 Drug substance, Drug product 2016-11-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203469-002 9029533 2026-12-22 U-1283 2015-06-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203469-002 9029533 2026-12-22 U-1700 2015-06-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203469-002 9029533 2026-12-22 U-1701 2015-06-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203469-002 9029533 2026-12-22 U-836 2015-06-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203469-002 9029533 2026-12-22 U-1699 2015-06-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203469-002 8114874 2027-01-24 Drug substance, Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203469-002 11192895 2033-12-12 U-1700 2022-01-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203469-002 11192895 2033-12-12 U-1701 2022-01-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203469-002 11192895 2033-12-12 U-1948 2022-01-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203469-002 11192897 2033-12-12 U-1700 Drug substance 2022-01-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203469-002 11192897 2033-12-12 U-1701 Drug substance 2022-01-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203469-002 11192897 2033-12-12 U-1948 Drug substance 2022-01-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203469-002 11384086 2033-12-12 U-1948 Drug substance, Drug product 2022-08-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203469-002 11384086 2033-12-12 U-1701 Drug substance, Drug product 2022-08-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203469-002 11384086 2033-12-12 U-1700 Drug substance, Drug product 2022-08-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203469-002 9493470 2033-12-12 U-1948 Drug substance, Drug product 2016-11-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203469-002 9493470 2033-12-12 U-1700 Drug substance, Drug product 2016-11-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203469-003 9029533 2026-12-22 U-1701 2015-06-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203469-003 9029533 2026-12-22 U-836 2015-06-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203469-003 9029533 2026-12-22 U-1283 2015-06-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203469-003 9029533 2026-12-22 U-1700 2015-06-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203469-003 9029533 2026-12-22 U-1699 2015-06-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203469-003 8114874 2027-01-24 Drug substance, Drug product 2015-06-09 84e616aacf4f…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 6 · 220 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.