Home NDC 63020-536 Iclusig
Product NDC 63020-536
11-digit product format 630200536
Labeler code 63020
Product ID 63020-536_1987d030-31ce-4d26-9871-0a3e7ee4e522
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ponatinib hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Takeda Pharmaceuticals America, Inc.
Application NDA203469
Marketing category NDA
Marketing start 2021-01-11
Substance PONATINIB HYDROCHLORIDE
Active strength 10 mg/1
Pharmacologic classes Kinase Inhibitor [EPC], Protein Kinase 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 1 .
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 4 · 158 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 2026-02-19 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…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203469-001 ICLUSIG EQ 15MG BASE TABLET / ORAL RLD 2012-12-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203469-002 ICLUSIG EQ 45MG BASE TABLET / ORAL RLD, RS 2012-12-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203469-003 ICLUSIG EQ 30MG BASE TABLET / ORAL RLD 2015-04-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203469-004 ICLUSIG EQ 10MG BASE TABLET / ORAL RLD 2020-12-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N203469-001 ICLUSIG EQ 15MG BASE TABLET / ORAL RLD 2012-12-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N203469-002 ICLUSIG EQ 45MG BASE TABLET / ORAL RLD, RS 2012-12-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N203469-003 ICLUSIG EQ 30MG BASE TABLET / ORAL RLD 2015-04-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N203469-004 ICLUSIG EQ 10MG BASE TABLET / ORAL RLD 2020-12-18 d06236e962d9…
Observed Orange Book patent history# Patent history page 1 of 59 · 2,356 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 N203469-001 9029533 2026-12-22 U-1700 2015-06-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203469-001 9029533 2026-12-22 U-836 2015-06-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203469-001 9029533 2026-12-22 U-1701 2015-06-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203469-001 9029533 2026-12-22 U-1699 2015-06-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203469-001 9029533 2026-12-22 U-1283 2015-06-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203469-001 8114874 2027-01-24 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203469-001 11192895 2033-12-12 U-1700 2022-01-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203469-001 11192895 2033-12-12 U-1701 2022-01-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203469-001 11192895 2033-12-12 U-1948 2022-01-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203469-001 11192897 2033-12-12 U-1700 Drug substance 2022-01-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203469-001 11192897 2033-12-12 U-1701 Drug substance 2022-01-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203469-001 11192897 2033-12-12 U-1948 Drug substance 2022-01-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203469-001 11384086 2033-12-12 U-1700 Drug substance, Drug product 2022-08-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203469-001 11384086 2033-12-12 U-1948 Drug substance, Drug product 2022-08-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203469-001 11384086 2033-12-12 U-1701 Drug substance, Drug product 2022-08-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203469-001 9493470 2033-12-12 U-1700 Drug substance, Drug product 2016-11-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203469-001 9493470 2033-12-12 U-1948 Drug substance, Drug product 2016-11-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203469-002 9029533 2026-12-22 U-1283 2015-06-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203469-002 9029533 2026-12-22 U-1700 2015-06-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203469-002 9029533 2026-12-22 U-1701 2015-06-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203469-002 9029533 2026-12-22 U-836 2015-06-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203469-002 9029533 2026-12-22 U-1699 2015-06-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203469-002 8114874 2027-01-24 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203469-002 11192895 2033-12-12 U-1700 2022-01-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203469-002 11192895 2033-12-12 U-1701 2022-01-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203469-002 11192895 2033-12-12 U-1948 2022-01-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203469-002 11192897 2033-12-12 U-1700 Drug substance 2022-01-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203469-002 11192897 2033-12-12 U-1701 Drug substance 2022-01-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203469-002 11192897 2033-12-12 U-1948 Drug substance 2022-01-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203469-002 11384086 2033-12-12 U-1948 Drug substance, Drug product 2022-08-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203469-002 11384086 2033-12-12 U-1701 Drug substance, Drug product 2022-08-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203469-002 11384086 2033-12-12 U-1700 Drug substance, Drug product 2022-08-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203469-002 9493470 2033-12-12 U-1948 Drug substance, Drug product 2016-11-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203469-002 9493470 2033-12-12 U-1700 Drug substance, Drug product 2016-11-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203469-003 9029533 2026-12-22 U-1701 2015-06-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203469-003 9029533 2026-12-22 U-836 2015-06-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203469-003 9029533 2026-12-22 U-1283 2015-06-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203469-003 9029533 2026-12-22 U-1700 2015-06-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203469-003 9029533 2026-12-22 U-1699 2015-06-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203469-003 8114874 2027-01-24 Drug substance, Drug product 2015-06-09 011fe1cb6892…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 6 · 204 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Iclusig
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PONATINIB HYDROCHLORIDE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 96R6PU3D8J Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1364352 Internal RxNorm lookup 1364358 Internal RxNorm lookup 1364360 Internal RxNorm lookup 1364362 Internal RxNorm lookup 1726637 Internal RxNorm lookup 1726639 Internal RxNorm lookup 2473040 Internal RxNorm lookup 2473042 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63020-536-30 Iclusig 30 in 1 BOTTLE TABLET, FILM COATED 30 19
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63020-536 ICLUSIG (PONATINIB HYDROCHLORIDE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.] 17 Current NDC, Legacy NDC, 1 package rows 20241222_16d804b6-4957-43ee-b18c-3b36ec37c5ac.zip
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Iclusig PONATINIB HYDROCHLORIDE Takeda Pharmaceuticals America, Inc. 16d804b6-4957-43ee-b18c-3b36ec37c5ac 2026-04-29 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 203469 application number: NDA203469 ndc (product): 63020-536
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 63020-536-30 63020053630 30 TABLET, FILM COATED in 1 BOTTLE (63020-536-30) 2021-01-11 0000-00-00 No No Current