Home NDC 63539-193 BOSULIF
Product NDC 63539-193
11-digit product format 635390193
Labeler code 63539
Product ID 63539-193_6550da0f-5049-4056-b705-ffbcf2ac00cf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bosutinib
Dosage form TABLET, FILM COATED
Route ORAL
Labeler U.S. Pharmaceuticals
Application NDA203341
Marketing category NDA
Marketing start 2012-09-04
Substance BOSUTINIB MONOHYDRATE
Active strength 400 mg/1
Pharmacologic classes Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Kinase Inhibitor [EPC]
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 42 .
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 N203341-001 BOSULIF BOSUTINIB MONOHYDRATE EQ 100MG BASE TABLET / ORAL AB RLD, RS 2012-09-04 N203341-002 BOSULIF BOSUTINIB MONOHYDRATE EQ 500MG BASE TABLET / ORAL AB RLD 2012-09-04 N203341-003 BOSULIF BOSUTINIB MONOHYDRATE EQ 400MG BASE TABLET / ORAL AB RLD 2017-10-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 33 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 12 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 · 126 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 2026-08-18 06:07:40 2026-07 N203341-001 BOSULIF EQ 100MG BASE TABLET / ORAL AB RLD, RS 2012-09-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203341-002 BOSULIF EQ 500MG BASE TABLET / ORAL AB RLD 2012-09-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203341-003 BOSULIF EQ 400MG BASE TABLET / ORAL AB RLD 2017-10-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N203341-001 BOSULIF EQ 100MG BASE TABLET / ORAL AB RLD, RS 2012-09-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203341-002 BOSULIF EQ 500MG BASE TABLET / ORAL AB RLD 2012-09-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203341-003 BOSULIF EQ 400MG BASE TABLET / ORAL RLD 2017-10-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203341-001 BOSULIF EQ 100MG BASE TABLET / ORAL AB RLD, RS 2012-09-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203341-002 BOSULIF EQ 500MG BASE TABLET / ORAL AB RLD 2012-09-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203341-003 BOSULIF EQ 400MG BASE TABLET / ORAL RLD 2017-10-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203341-001 BOSULIF EQ 100MG BASE TABLET / ORAL AB RLD, RS 2012-09-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203341-002 BOSULIF EQ 500MG BASE TABLET / ORAL AB RLD 2012-09-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203341-003 BOSULIF EQ 400MG BASE TABLET / ORAL RLD 2017-10-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203341-001 BOSULIF EQ 100MG BASE TABLET / ORAL RLD, RS 2012-09-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203341-002 BOSULIF EQ 500MG BASE TABLET / ORAL RLD 2012-09-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203341-003 BOSULIF EQ 400MG BASE TABLET / ORAL RLD 2017-10-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203341-001 BOSULIF EQ 100MG BASE TABLET / ORAL RLD, RS 2012-09-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203341-002 BOSULIF EQ 500MG BASE TABLET / ORAL RLD 2012-09-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203341-003 BOSULIF EQ 400MG BASE TABLET / ORAL RLD 2017-10-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203341-001 BOSULIF EQ 100MG BASE TABLET / ORAL RLD, RS 2012-09-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203341-002 BOSULIF EQ 500MG BASE TABLET / ORAL RLD 2012-09-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203341-003 BOSULIF EQ 400MG BASE TABLET / ORAL RLD 2017-10-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203341-001 BOSULIF EQ 100MG BASE TABLET / ORAL RLD, RS 2012-09-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203341-002 BOSULIF EQ 500MG BASE TABLET / ORAL RLD 2012-09-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203341-003 BOSULIF EQ 400MG BASE TABLET / ORAL RLD 2017-10-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203341-001 BOSULIF EQ 100MG BASE TABLET / ORAL RLD, RS 2012-09-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203341-002 BOSULIF EQ 500MG BASE TABLET / ORAL RLD 2012-09-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203341-003 BOSULIF EQ 400MG BASE TABLET / ORAL RLD 2017-10-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203341-001 BOSULIF EQ 100MG BASE TABLET / ORAL RLD, RS 2012-09-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203341-002 BOSULIF EQ 500MG BASE TABLET / ORAL RLD 2012-09-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203341-003 BOSULIF EQ 400MG BASE TABLET / ORAL RLD 2017-10-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N203341-001 BOSULIF EQ 100MG BASE TABLET / ORAL RLD, RS 2012-09-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N203341-002 BOSULIF EQ 500MG BASE TABLET / ORAL RLD 2012-09-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N203341-003 BOSULIF EQ 400MG BASE TABLET / ORAL RLD 2017-10-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N203341-001 BOSULIF EQ 100MG BASE TABLET / ORAL RLD, RS 2012-09-04 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N203341-002 BOSULIF EQ 500MG BASE TABLET / ORAL RLD 2012-09-04 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N203341-003 BOSULIF EQ 400MG BASE TABLET / ORAL RLD 2017-10-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N203341-001 BOSULIF EQ 100MG BASE TABLET / ORAL RLD, RS 2012-09-04 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N203341-002 BOSULIF EQ 500MG BASE TABLET / ORAL RLD 2012-09-04 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N203341-003 BOSULIF EQ 400MG BASE TABLET / ORAL RLD 2017-10-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N203341-001 BOSULIF EQ 100MG BASE TABLET / ORAL RLD, RS 2012-09-04 1e350fbaab3a…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 28 · 1,101 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N203341-001 7417148 2025-12-11 U-1283 2012-09-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203341-001 7417148 2025-12-11 U-3708 2012-09-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203341-001 7417148 2025-12-11 U-3707 2012-09-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203341-001 7919625 2025-12-11 Drug product 2012-09-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203341-001 7417148*PED 2026-06-11 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203341-001 7919625*PED 2026-06-11 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203341-001 7767678 2026-11-23 Drug substance, Drug product 2012-09-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203341-001 7767678*PED 2027-05-23 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203341-001 11103497 2034-02-28 U-3216 2021-09-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203341-001 11103497 2034-02-28 U-3217 2021-09-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203341-001 11103497*PED 2034-08-28 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203341-002 7417148 2025-12-11 U-1283 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203341-002 7417148 2025-12-11 U-3707 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203341-002 7417148 2025-12-11 U-3708 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203341-002 7919625 2025-12-11 Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203341-002 7417148*PED 2026-06-11 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203341-002 7919625*PED 2026-06-11 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203341-002 7767678 2026-11-23 Drug substance, Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203341-002 7767678*PED 2027-05-23 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203341-002 11103497 2034-02-28 U-3216 2021-09-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203341-002 11103497 2034-02-28 U-3217 2021-09-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203341-002 11103497*PED 2034-08-28 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203341-003 7417148 2025-12-11 U-1283 2017-11-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203341-003 7417148 2025-12-11 U-3708 2017-11-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203341-003 7417148 2025-12-11 U-3707 2017-11-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203341-003 7919625 2025-12-11 Drug product 2017-11-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203341-003 7417148*PED 2026-06-11 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203341-003 7919625*PED 2026-06-11 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203341-003 7767678 2026-11-23 Drug substance, Drug product 2017-11-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203341-003 7767678*PED 2027-05-23 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203341-003 11103497 2034-02-28 U-3216 2021-09-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203341-003 11103497 2034-02-28 U-3217 2021-09-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203341-003 11103497*PED 2034-08-28 Pediatric extension caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N203341-001 7417148 2025-12-11 U-1283 2012-09-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203341-001 7417148 2025-12-11 U-3708 2012-09-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203341-001 7417148 2025-12-11 U-3707 2012-09-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203341-001 7919625 2025-12-11 Drug product 2012-09-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203341-001 7417148*PED 2026-06-11 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203341-001 7919625*PED 2026-06-11 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203341-001 7767678 2026-11-23 Drug substance, Drug product 2012-09-25 011fe1cb6892…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 12 · 441 observed states.
Additional Listing Data#
Finished product Yes
Brand name base BOSULIF
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BOSUTINIB MONOHYDRATE 400 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 844ZJE6I55 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1307624 Internal RxNorm lookup 1307630 Internal RxNorm lookup 1987732 Internal RxNorm lookup 1987734 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 63539-193-30 BOSULIF 30 in 1 BOTTLE TABLET, FILM COATED 30 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BOSUTINIB MONOHYDRATE ACTIVE INGREDIENT 844ZJE6I55 BOSULIF (BOSUTINIB MONOHYDRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS] 1 BOSUTINIB ACTIVE MOIETY 5018V4AEZ0 BOSULIF (BOSUTINIB MONOHYDRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U BOSULIF (BOSUTINIB MONOHYDRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 BOSULIF (BOSUTINIB MONOHYDRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT BOSULIF (BOSUTINIB MONOHYDRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 BOSULIF (BOSUTINIB MONOHYDRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS] 1 POLOXAMER 188 INACTIVE INGREDIENT LQA7B6G8JG BOSULIF (BOSUTINIB MONOHYDRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS] 1 POLYETHYLENE GLYCOL 3350 INACTIVE INGREDIENT G2M7P15E5P BOSULIF (BOSUTINIB MONOHYDRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS] 1 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 BOSULIF (BOSUTINIB MONOHYDRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS] 1 POVIDONE K25 INACTIVE INGREDIENT K0KQV10C35 BOSULIF (BOSUTINIB MONOHYDRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U BOSULIF (BOSUTINIB MONOHYDRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP BOSULIF (BOSUTINIB MONOHYDRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63539-193 BOSULIF (BOSUTINIB) TABLET, FILM COATED [U.S. PHARMACEUTICALS] 4 Current NDC, Legacy NDC, 1 package rows 20250328_d5929f91-6496-4c0e-97e8-0bd524e15763.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 · 2 matching rows.
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 63539-193-30 63539019330 30 TABLET, FILM COATED in 1 BOTTLE (63539-193-30) 2018-02-21 0000-00-00 No No Current