FDA.reportPublic FDA data

bosutinib 500 MG Oral Tablet

RxCUI
1307633
RxNorm name
bosutinib 500 MG Oral Tablet
Display name
Bosutinib (Oral Pill)
Full name
bosutinib 500 MG Oral Tablet
Term type
SCD
Status
Active
Strength
500 mg
Dose form
Tab
Route
Oral Pill
Updated
2026-07-22 07:08:57

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
102012
Active start
102012
Multiple ingredient
NO
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
bosutinib500 MG / 1 EACHbosutinibbosutinib

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Tablet317541

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
bosutinib1307619

Source Vocabulary Codes#

Code type, Value, Category table
Code typeValueCategory
PRESCRIBABLEYATTRIBUTES
RXNAV_STRbosutinib 500 MG Oral TabletNAMES
RxNorm Namebosutinib 500 MG Oral TabletNAMES
RxNorm Synonymbosutinib 500 MG (as bosutinib monohydrate 516.98 MG) Oral TabletNAMES
TTYSCDATTRIBUTES
SPL_SET_ID2ea1617f-41d3-479a-87d5-177013d39193CODES
SPL_SET_ID8f3e9739-8ec1-4ea9-b1bc-185fd07d84e4CODES
RxCUI1307633CODES
MMSL_CODECD27855CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
46708-312-3046708-312Bosutinib BosutinibAlembic Pharmaceuticals LimitedANDA209543
62332-312-3062332-312Bosutinib BosutinibAlembic Pharmaceuticals Inc.ANDA209543

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
ANDA20954346708-312Bosutinib BosutinibANDAAlembic Pharmaceuticals Limited

RxNav Current And Historical NDCs#

NDC11, Source, Active table
NDC11SourceActive
46708031230rxnav_ndcsyes
62332031230rxnav_ndcsyes

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
adc84ad5-a04d-4fee-9ba8-91f7abd928e3bosutinib 500 MG (as bosutinib monohydrate 516.98 MG) Oral TabletSY32These highlights do not include all the information needed to use BOSULIF safely and effectively. See full prescribing information for BOSULIF. BOSULIF ® (bosutinib) tablets, for oral use BOSULIF ® (bosutinib) capsules, for oral use Initial U.S. Approval: 201220260310
adc84ad5-a04d-4fee-9ba8-91f7abd928e3bosutinib 500 MG Oral TabletPSN32These highlights do not include all the information needed to use BOSULIF safely and effectively. See full prescribing information for BOSULIF. BOSULIF ® (bosutinib) tablets, for oral use BOSULIF ® (bosutinib) capsules, for oral use Initial U.S. Approval: 201220260310
adc84ad5-a04d-4fee-9ba8-91f7abd928e3bosutinib 500 MG Oral TabletSCD32These highlights do not include all the information needed to use BOSULIF safely and effectively. See full prescribing information for BOSULIF. BOSULIF ® (bosutinib) tablets, for oral use BOSULIF ® (bosutinib) capsules, for oral use Initial U.S. Approval: 201220260310
2ea1617f-41d3-479a-87d5-177013d39193bosutinib 500 MG Oral TabletSCD20These highlights do not include all the information needed to use BOSUTINIB TABLETS safely and effectively. See full prescribing information for BOSUTINIB TABLETS. BOSUTINIB tablets, for oral use Initial U.S. Approval: 201220260520
2ea1617f-41d3-479a-87d5-177013d39193bosutinib 500 MG Oral TabletPSN20These highlights do not include all the information needed to use BOSUTINIB TABLETS safely and effectively. See full prescribing information for BOSUTINIB TABLETS. BOSUTINIB tablets, for oral use Initial U.S. Approval: 201220260520
2ea1617f-41d3-479a-87d5-177013d39193bosutinib 500 MG (as bosutinib monohydrate 516.98 MG) Oral TabletSY20These highlights do not include all the information needed to use BOSUTINIB TABLETS safely and effectively. See full prescribing information for BOSUTINIB TABLETS. BOSUTINIB tablets, for oral use Initial U.S. Approval: 201220260520
8f3e9739-8ec1-4ea9-b1bc-185fd07d84e4bosutinib 500 MG Oral TabletSCD2These highlights do not include all the information needed to use BOSUTINIB TABLETS safely and effectively. See full prescribing information for BOSUTINIB TABLETS. BOSUTINIB tablets, for oral use Initial U.S. Approval: 201220260522
8f3e9739-8ec1-4ea9-b1bc-185fd07d84e4bosutinib 500 MG (as bosutinib monohydrate 516.98 MG) Oral TabletSY2These highlights do not include all the information needed to use BOSUTINIB TABLETS safely and effectively. See full prescribing information for BOSUTINIB TABLETS. BOSUTINIB tablets, for oral use Initial U.S. Approval: 201220260522
8f3e9739-8ec1-4ea9-b1bc-185fd07d84e4bosutinib 500 MG Oral TabletPSN2These highlights do not include all the information needed to use BOSUTINIB TABLETS safely and effectively. See full prescribing information for BOSUTINIB TABLETS. BOSUTINIB tablets, for oral use Initial U.S. Approval: 201220260522

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
8f3e9739-8ec1-4ea9-b1bc-185fd07d84e4These highlights do not include all the information needed to use BOSUTINIB TABLETS safely and effectively. See full prescribing information for BOSUTINIB TABLETS. BOSUTINIB tablets, for oral use Initial U.S. Approval: 2012Alembic Pharmaceuticals Limited20260522
2ea1617f-41d3-479a-87d5-177013d39193These highlights do not include all the information needed to use BOSUTINIB TABLETS safely and effectively. See full prescribing information for BOSUTINIB TABLETS. BOSUTINIB tablets, for oral use Initial U.S. Approval: 2012Alembic Pharmaceuticals Inc. | Alembic Pharmaceuticals Limited20260520
2ea1617f-41d3-479a-87d5-177013d39193These highlights do not include all the information needed to use BOSUTINIB TABLETS safely and effectively. See full prescribing information for BOSUTINIB TABLETS. BOSUTINIB tablets, for oral use Initial U.S. Approval: 2012Alembic Pharmaceuticals Inc. | Alembic Pharmaceuticals Limited20260519
8f3e9739-8ec1-4ea9-b1bc-185fd07d84e4These highlights do not include all the information needed to use BOSUTINIB TABLETS safely and effectively. See full prescribing information for BOSUTINIB TABLETS. BOSUTINIB tablets, for oral use Initial U.S. Approval: 2012Alembic Pharmaceuticals Limited20260519

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCL01EABCR-ABL tyrosine kinase inhibitorsATC1-4bosutinib
FDASPLN0000175605Kinase InhibitorEPChas_epcbosutinib
FDASPLN0000020009Bcr-Abl Tyrosine Kinase InhibitorsMOAhas_moabosutinib
MEDRTD000814Aniline CompoundsCHEMhas_ingredientbosutinib
MEDRTD009570NitrilesCHEMhas_ingredientbosutinib
MEDRTD011804QuinolinesCHEMhas_ingredientbosutinib
MEDRTD004342Drug HypersensitivityDISEASEci_withbosutinib
MEDRTD015464Leukemia, Myelogenous, Chronic, BCR-ABL PositiveDISEASEmay_treatbosutinib
MEDRTN0000020001Tyrosine Kinase InhibitorsMOAhas_moabosutinib
MEDRTN0000175672Cellular Proliferation AlterationPEhas_pebosutinib

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH500 MG
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESPRESCRIBABLEY
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
ATTRIBUTESTTYSCD
CODESANDAANDA209543
CODESMMSL_CODECD27855
CODESRxCUI1307633
CODESSNOMEDCT1145411008
CODESSPL_SET_ID2ea1617f-41d3-479a-87d5-177013d39193
CODESSPL_SET_ID8f3e9739-8ec1-4ea9-b1bc-185fd07d84e4
CODESVUID4031693
NAMESPrescribable Synonymbosutinib 500 MG Oral Tablet
NAMESRXNAV_STRbosutinib 500 MG Oral Tablet
NAMESRxNorm Namebosutinib 500 MG Oral Tablet
NAMESRxNorm Synonymbosutinib 500 MG (as bosutinib monohydrate 516.98 MG) Oral Tablet
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon
SOURCESSourceNational Drug Data File Plus Source Vocabulary
SOURCESSourceUS Edition of SNOMED_CT
SOURCESSourceVeterans Health Administration National Drug File