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, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRBosulif 100 MG Oral Tablet1NAMES
RxNorm Namebosutinib 100 MG Oral Tablet [Bosulif]1NAMES
RxNorm Synonym
2 linked values
2NAMES
TTYSBD1ATTRIBUTES
SPL_SET_IDadc84ad5-a04d-4fee-9ba8-91f7abd928e31CODES
RxCUI13076301CODES
MMSL_CODEBD278541CODES

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#

RxNav current and historical NDC rows page 1 of 1 · 2 matching rows.

NDC11, Source, Active table
NDC11SourceActive
00069013501rxnav_ndcsyes
63539011701rxnav_historical

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BOSULIFBOSUTINIBU.S. Pharmaceuticalsd5929f91-6496-4c0e-97e8-0bd524e157632026-05-28Warnings, Adverse reactionsExact identifier
ndc11 (package): 63539011701
rxcui: 1307630
BOSULIFBOSUTINIBPfizer Laboratories Div Pfizer Incadc84ad5-a04d-4fee-9ba8-91f7abd928e32026-03-10Warnings, Adverse reactionsExact identifier
ndc (package): 0069-0135-01
ndc (product): 0069-0135
ndc11 (package): 00069013501
rxcui: 1307630

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
adc84ad5-a04d-4fee-9ba8-91f7abd928e3Bosulif 100 MG Oral Tablet [PSN] · bosutinib 100 MG Oral Tablet [Bosulif] [SBD] · Bosulif 100 MG (as bosutinib monohydrate 103.4 MG) Oral Tablet [SY] · Bosulif 100 MG Oral Tablet [SY]432These 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 Tablet [PSN] · bosutinib 100 MG Oral Tablet [Bosulif] [SBD] · Bosulif 100 MG (as bosutinib monohydrate 103.4 MG) Oral Tablet [SY] · Bosulif 100 MG Oral Tablet [SY]46These 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

Recently Linked 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
05823b10-9646-4fc4-a0f0-e05b946baa1eNational Council for Prescription Drug Programs20130213

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
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESNDANDA203341
NAMESPrescribable SynonymBosulif 100 MG Oral Tablet
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon