FDA.reportPublic FDA data

bosutinib 100 MG Oral Tablet [Bosulif]

RxCUI
1307630
RxNorm name
bosutinib 100 MG Oral Tablet [Bosulif]
Display name
BOSULIF (Oral Pill)
Full name
bosutinib 100 MG Oral Tablet [Bosulif]
Term type
SBD
Status
Active
Strength
100 mg
Dose form
Tab
Route
Oral Pill
Updated
2026-07-22 07:08:54

RxNorm Status History#

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

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
bosutinib100 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_STRBosulif 100 MG Oral TabletNAMES
RxNorm Namebosutinib 100 MG Oral Tablet [Bosulif]NAMES
RxNorm SynonymBosulif 100 MG (as bosutinib monohydrate 103.4 MG) Oral TabletNAMES
RxNorm SynonymBosulif 100 MG Oral TabletNAMES
TTYSBDATTRIBUTES
SPL_SET_IDadc84ad5-a04d-4fee-9ba8-91f7abd928e3CODES
RxCUI1307630CODES
MMSL_CODEBD27854CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
0069-0135-010069-0135BOSULIF BosutinibPfizer Laboratories Div Pfizer IncNDA203341

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
NDA2033410069-0135BOSULIF BosutinibNDAPfizer Laboratories Div Pfizer Inc

RxNav Current And Historical NDCs#

NDC11, Source, Active table
NDC11SourceActive
00069013501rxnav_ndcsyes
63539011701rxnav_historical

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
adc84ad5-a04d-4fee-9ba8-91f7abd928e3Bosulif 100 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-9ba8-91f7abd928e3Bosulif 100 MG (as bosutinib monohydrate 103.4 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-9ba8-91f7abd928e3Bosulif 100 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 100 MG Oral Tablet [Bosulif]SBD32These 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
d5929f91-6496-4c0e-97e8-0bd524e15763Bosulif 100 MG Oral TabletPSN6These 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: 201220260528
d5929f91-6496-4c0e-97e8-0bd524e15763bosutinib 100 MG Oral Tablet [Bosulif]SBD6These 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: 201220260528
d5929f91-6496-4c0e-97e8-0bd524e15763Bosulif 100 MG Oral TabletSY6These 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: 201220260528
d5929f91-6496-4c0e-97e8-0bd524e15763Bosulif 100 MG (as bosutinib monohydrate 103.4 MG) Oral TabletSY6These 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: 201220260528

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
d5929f91-6496-4c0e-97e8-0bd524e15763These 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: 2012U.S. Pharmaceuticals | Pfizer Manufacturing Deutschland GmbH | Pfizer Ireland Pharmaceuticals Unlimited Company20260528
d5929f91-6496-4c0e-97e8-0bd524e15763These 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: 2012U.S. Pharmaceuticals | Pfizer Manufacturing Deutschland GmbH | Pfizer Ireland Pharmaceuticals Unlimited Company20260318
adc84ad5-a04d-4fee-9ba8-91f7abd928e3These 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: 2012Pfizer Laboratories Div Pfizer Inc | Pfizer Manufacturing Deutschland GmbH | Pfizer Ireland Pharmaceuticals Unlimited Company20260310

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_STRENGTH100 MG
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESPRESCRIBABLEY
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
ATTRIBUTESTTYSBD
CODESMMSL_CODEBD27854
CODESNDANDA203341
CODESRxCUI1307630
CODESSPL_SET_IDadc84ad5-a04d-4fee-9ba8-91f7abd928e3
NAMESPrescribable SynonymBosulif 100 MG Oral Tablet
NAMESRXNAV_STRBosulif 100 MG Oral Tablet
NAMESRxNorm Namebosutinib 100 MG Oral Tablet [Bosulif]
NAMESRxNorm SynonymBosulif 100 MG (as bosutinib monohydrate 103.4 MG) Oral Tablet
NAMESRxNorm SynonymBosulif 100 MG Oral Tablet
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon