Home NDC 0069-1014 BOSULIF
Product NDC 0069-1014
11-digit product format 000691014
Labeler code 0069
Product ID 0069-1014_ca8600d9-46e6-402d-89f9-bc6a156bf751
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bosutinib
Dosage form CAPSULE
Route ORAL
Labeler Pfizer Laboratories Div Pfizer Inc
Application NDA217729
Marketing category NDA
Marketing start 2024-01-02
Substance BOSUTINIB MONOHYDRATE
Active strength 100 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N217729-001 BOSULIF BOSUTINIB MONOHYDRATE EQ 50MG BASE CAPSULE / ORAL RLD 2023-09-26 N217729-002 BOSULIF BOSUTINIB MONOHYDRATE EQ 100MG BASE CAPSULE / ORAL RLD, RS 2023-09-26
Orange Book patents# Current patent rows page 1 of 1 · 20 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N217729-001 7417148 2025-12-11 U-3707 2023-10-26 N217729-001 7417148 2025-12-11 U-3708 2023-10-26 N217729-001 7919625 2025-12-11 Drug product 2023-10-26 N217729-001 7417148*PED 2026-06-11 Pediatric extension N217729-001 7919625*PED 2026-06-11 Pediatric extension N217729-001 7767678 2026-11-23 Drug substance, Drug product 2023-10-26 N217729-001 7767678*PED 2027-05-23 Pediatric extension N217729-001 11103497 2034-02-28 U-3216 2023-10-26 N217729-001 11103497 2034-02-28 U-3217 2023-10-26 N217729-001 11103497*PED 2034-08-28 Pediatric extension N217729-002 7417148 2025-12-11 U-3707 2023-10-26 N217729-002 7417148 2025-12-11 U-3708 2023-10-26 N217729-002 7919625 2025-12-11 Drug product 2023-10-26 N217729-002 7417148*PED 2026-06-11 Pediatric extension N217729-002 7919625*PED 2026-06-11 Pediatric extension N217729-002 7767678 2026-11-23 Drug substance, Drug product 2023-10-26 N217729-002 7767678*PED 2027-05-23 Pediatric extension N217729-002 11103497 2034-02-28 U-3216 2023-10-26 N217729-002 11103497 2034-02-28 U-3217 2023-10-26 N217729-002 11103497*PED 2034-08-28 Pediatric extension
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 2 · 42 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 N217729-001 BOSULIF EQ 50MG BASE CAPSULE / ORAL RLD 2023-09-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217729-002 BOSULIF EQ 100MG BASE CAPSULE / ORAL RLD, RS 2023-09-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N217729-001 BOSULIF EQ 50MG BASE CAPSULE / ORAL RLD 2023-09-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217729-002 BOSULIF EQ 100MG BASE CAPSULE / ORAL RLD, RS 2023-09-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217729-001 BOSULIF EQ 50MG BASE CAPSULE / ORAL RLD 2023-09-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217729-002 BOSULIF EQ 100MG BASE CAPSULE / ORAL RLD, RS 2023-09-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217729-001 BOSULIF EQ 50MG BASE CAPSULE / ORAL RLD 2023-09-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217729-002 BOSULIF EQ 100MG BASE CAPSULE / ORAL RLD, RS 2023-09-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217729-001 BOSULIF EQ 50MG BASE CAPSULE / ORAL RLD 2023-09-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217729-002 BOSULIF EQ 100MG BASE CAPSULE / ORAL RLD, RS 2023-09-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217729-001 BOSULIF EQ 50MG BASE CAPSULE / ORAL RLD 2023-09-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217729-002 BOSULIF EQ 100MG BASE CAPSULE / ORAL RLD, RS 2023-09-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217729-001 BOSULIF EQ 50MG BASE CAPSULE / ORAL RLD 2023-09-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217729-002 BOSULIF EQ 100MG BASE CAPSULE / ORAL RLD, RS 2023-09-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217729-001 BOSULIF EQ 50MG BASE CAPSULE / ORAL RLD 2023-09-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217729-002 BOSULIF EQ 100MG BASE CAPSULE / ORAL RLD, RS 2023-09-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217729-001 BOSULIF EQ 50MG BASE CAPSULE / ORAL RLD 2023-09-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217729-002 BOSULIF EQ 100MG BASE CAPSULE / ORAL RLD, RS 2023-09-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217729-001 BOSULIF EQ 50MG BASE CAPSULE / ORAL RLD 2023-09-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217729-002 BOSULIF EQ 100MG BASE CAPSULE / ORAL RLD, RS 2023-09-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N217729-001 BOSULIF EQ 50MG BASE CAPSULE / ORAL RLD 2023-09-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N217729-002 BOSULIF EQ 100MG BASE CAPSULE / ORAL RLD, RS 2023-09-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N217729-001 BOSULIF EQ 50MG BASE CAPSULE / ORAL RLD 2023-09-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N217729-002 BOSULIF EQ 100MG BASE CAPSULE / ORAL RLD, RS 2023-09-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N217729-001 BOSULIF EQ 50MG BASE CAPSULE / ORAL RLD 2023-09-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N217729-002 BOSULIF EQ 100MG BASE CAPSULE / ORAL RLD, RS 2023-09-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N217729-001 BOSULIF EQ 50MG BASE CAPSULE / ORAL RLD 2023-09-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N217729-002 BOSULIF EQ 100MG BASE CAPSULE / ORAL RLD, RS 2023-09-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N217729-001 BOSULIF EQ 50MG BASE CAPSULE / ORAL RLD 2023-09-26 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N217729-002 BOSULIF EQ 100MG BASE CAPSULE / ORAL RLD, RS 2023-09-26 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N217729-001 BOSULIF EQ 50MG BASE CAPSULE / ORAL RLD 2023-09-26 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N217729-002 BOSULIF EQ 100MG BASE CAPSULE / ORAL RLD, RS 2023-09-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N217729-001 BOSULIF EQ 50MG BASE CAPSULE / ORAL RLD 2023-09-26 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N217729-002 BOSULIF EQ 100MG BASE CAPSULE / ORAL RLD, RS 2023-09-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N217729-001 BOSULIF EQ 50MG BASE CAPSULE / ORAL RLD 2023-09-26 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N217729-002 BOSULIF EQ 100MG BASE CAPSULE / ORAL RLD, RS 2023-09-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N217729-001 BOSULIF EQ 50MG BASE CAPSULE / ORAL RLD 2023-09-26 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N217729-002 BOSULIF EQ 100MG BASE CAPSULE / ORAL RLD, RS 2023-09-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N217729-001 BOSULIF EQ 50MG BASE CAPSULE / ORAL RLD, RS 2023-09-26 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N217729-002 BOSULIF EQ 100MG BASE CAPSULE / ORAL RLD 2023-09-26 9b2671bbb829…
Observed Orange Book patent history# Patent history page 1 of 12 · 452 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 N217729-001 7417148 2025-12-11 U-3707 2023-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217729-001 7417148 2025-12-11 U-3708 2023-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217729-001 7919625 2025-12-11 Drug product 2023-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217729-001 7417148*PED 2026-06-11 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217729-001 7919625*PED 2026-06-11 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217729-001 7767678 2026-11-23 Drug substance, Drug product 2023-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217729-001 7767678*PED 2027-05-23 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217729-001 11103497 2034-02-28 U-3216 2023-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217729-001 11103497 2034-02-28 U-3217 2023-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217729-001 11103497*PED 2034-08-28 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217729-002 7417148 2025-12-11 U-3707 2023-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217729-002 7417148 2025-12-11 U-3708 2023-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217729-002 7919625 2025-12-11 Drug product 2023-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217729-002 7417148*PED 2026-06-11 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217729-002 7919625*PED 2026-06-11 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217729-002 7767678 2026-11-23 Drug substance, Drug product 2023-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217729-002 7767678*PED 2027-05-23 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217729-002 11103497 2034-02-28 U-3216 2023-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217729-002 11103497 2034-02-28 U-3217 2023-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217729-002 11103497*PED 2034-08-28 Pediatric extension caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N217729-001 7417148 2025-12-11 U-3707 2023-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217729-001 7417148 2025-12-11 U-3708 2023-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217729-001 7919625 2025-12-11 Drug product 2023-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217729-001 7417148*PED 2026-06-11 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217729-001 7919625*PED 2026-06-11 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217729-001 7767678 2026-11-23 Drug substance, Drug product 2023-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217729-001 7767678*PED 2027-05-23 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217729-001 11103497 2034-02-28 U-3216 2023-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217729-001 11103497 2034-02-28 U-3217 2023-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217729-001 11103497*PED 2034-08-28 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217729-002 7417148 2025-12-11 U-3707 2023-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217729-002 7417148 2025-12-11 U-3708 2023-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217729-002 7919625 2025-12-11 Drug product 2023-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217729-002 7417148*PED 2026-06-11 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217729-002 7919625*PED 2026-06-11 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217729-002 7767678 2026-11-23 Drug substance, Drug product 2023-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217729-002 7767678*PED 2027-05-23 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217729-002 11103497 2034-02-28 U-3216 2023-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217729-002 11103497 2034-02-28 U-3217 2023-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217729-002 11103497*PED 2034-08-28 Pediatric extension 011fe1cb6892…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 4 · 160 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 100 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 · 10 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1307624 Internal RxNorm lookup 1307630 Internal RxNorm lookup 1307633 Internal RxNorm lookup 1307635 Internal RxNorm lookup 1987732 Internal RxNorm lookup 1987734 Internal RxNorm lookup 2669663 Internal RxNorm lookup 2669665 Internal RxNorm lookup 2672326 Internal RxNorm lookup 2672328 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 0069-1014-15 BOSULIF 150 in 1 BOTTLE CAPSULE 150 32
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 [PFIZER LABORATORIES DIV PFIZER INC] 8 BOSUTINIB ACTIVE MOIETY 5018V4AEZ0 BOSULIF (BOSUTINIB MONOHYDRATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC] 8 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U BOSULIF (BOSUTINIB MONOHYDRATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC] 8 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 BOSULIF (BOSUTINIB MONOHYDRATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC] 8 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 BOSULIF (BOSUTINIB MONOHYDRATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC] 8 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT BOSULIF (BOSUTINIB MONOHYDRATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC] 8 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 BOSULIF (BOSUTINIB MONOHYDRATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC] 8 POLOXAMER 188 INACTIVE INGREDIENT LQA7B6G8JG BOSULIF (BOSUTINIB MONOHYDRATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC] 8 POLYETHYLENE GLYCOL 3350 INACTIVE INGREDIENT G2M7P15E5P BOSULIF (BOSUTINIB MONOHYDRATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC] 8 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 BOSULIF (BOSUTINIB MONOHYDRATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC] 8 POVIDONE K25 INACTIVE INGREDIENT K0KQV10C35 BOSULIF (BOSUTINIB MONOHYDRATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC] 8 TALC INACTIVE INGREDIENT 7SEV7J4R1U BOSULIF (BOSUTINIB MONOHYDRATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC] 8 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP BOSULIF (BOSUTINIB MONOHYDRATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC] 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0069-1014 BOSULIF (BOSUTINIB) TABLET, FILM COATED BOSULIF (BOSUTINIB) CAPSULE [PFIZER LABORATORIES DIV PFIZER INC] 31 Current NDC, 1 package rows 20241215_adc84ad5-a04d-4fee-9ba8-91f7abd928e3.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0069-1014-15 00069101415 150 CAPSULE in 1 BOTTLE (0069-1014-15) 150 capsule 2024-01-02 No No Current