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
Ingredient	Strength	Base	Basis of strength
bosutinib	500 MG / 1 EACH	bosutinib	bosutinib

Dose Form Concepts#

Dose form, RxCUI table
Dose form	RxCUI
Oral Tablet	317541

Derived Ingredient Concepts#

Ingredient, RxCUI table
Ingredient	RxCUI
bosutinib	1307619

Source Vocabulary Codes#

Code type, Values, Count table
Code type	Values	Count	Category
PRESCRIBABLE	Y	1	ATTRIBUTES
RXNAV_STR	bosutinib 500 MG Oral Tablet	1	NAMES
RxNorm Name	bosutinib 500 MG Oral Tablet	1	NAMES
RxNorm Synonym	bosutinib 500 MG (as bosutinib monohydrate 516.98 MG) Oral Tablet	1	NAMES
TTY	SCD	1	ATTRIBUTES
SPL_SET_ID	2 linked values 2ea1617f-41d3-479a-87d5-177013d39193 8f3e9739-8ec1-4ea9-b1bc-185fd07d84e4	2	CODES
RxCUI	1307633	1	CODES
MMSL_CODE	CD27855	1	CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDC	Product NDC	Name	Labeler	Application
46708-312-30	46708-312	Bosutinib Bosutinib	Alembic Pharmaceuticals Limited	ANDA209543
62332-312-30	62332-312	Bosutinib Bosutinib	Alembic Pharmaceuticals Inc.	ANDA209543

Drugs@FDA Applications#

Application, NDC, Name table
Application	NDC	Name	Marketing category	Labeler
ANDA209543	46708-312	Bosutinib Bosutinib	ANDA	Alembic Pharmaceuticals Limited

RxNav Current And Historical NDCs#

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

NDC11, Source, Active table
NDC11	Source	Active
46708031230	rxnav_ndcs	yes
62332031230	rxnav_ndcs	yes

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bosutinib	BOSUTINIB	Alembic Pharmaceuticals Limited	8f3e9739-8ec1-4ea9-b1bc-185fd07d84e4	2026-05-22	Warnings, Adverse reactions	Exact identifier ndc (package): 46708-312-30 ndc (product): 46708-312 ndc11 (package): 46708031230 rxcui: 1307633
Bosutinib	BOSUTINIB	Alembic Pharmaceuticals Inc.	2ea1617f-41d3-479a-87d5-177013d39193	2026-05-20	Warnings, Adverse reactions	Exact identifier ndc (package): 62332-312-30 ndc (product): 62332-312 ndc11 (package): 62332031230 rxcui: 1307633
BOSULIF	BOSUTINIB	Pfizer Laboratories Div Pfizer Inc	adc84ad5-a04d-4fee-9ba8-91f7abd928e3	2026-03-10	Warnings, Adverse reactions	Exact identifier rxcui: 1307633

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 3 matching rows.

Set ID, RxNorm mappings, Terms table
Set ID	RxNorm mappings	Terms	SPL version	Label	Effective
adc84ad5-a04d-4fee-9ba8-91f7abd928e3	bosutinib 500 MG Oral Tablet [PSN] · bosutinib 500 MG Oral Tablet [SCD] · bosutinib 500 MG (as bosutinib monohydrate 516.98 MG) Oral Tablet [SY]	3	32	These 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: 2012	20260310
2ea1617f-41d3-479a-87d5-177013d39193	bosutinib 500 MG Oral Tablet [PSN] · bosutinib 500 MG Oral Tablet [SCD] · bosutinib 500 MG (as bosutinib monohydrate 516.98 MG) Oral Tablet [SY]	3	20	These 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: 2012	20260520
8f3e9739-8ec1-4ea9-b1bc-185fd07d84e4	bosutinib 500 MG Oral Tablet [PSN] · bosutinib 500 MG Oral Tablet [SCD] · bosutinib 500 MG (as bosutinib monohydrate 516.98 MG) Oral Tablet [SY]	3	2	These 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: 2012	20260522

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set ID	Title	Manufacturer	Effective
8f3e9739-8ec1-4ea9-b1bc-185fd07d84e4	These 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: 2012	Alembic Pharmaceuticals Limited	20260522
2ea1617f-41d3-479a-87d5-177013d39193	These 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: 2012	Alembic Pharmaceuticals Inc. \| Alembic Pharmaceuticals Limited	20260520
2ea1617f-41d3-479a-87d5-177013d39193	These 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: 2012	Alembic Pharmaceuticals Inc. \| Alembic Pharmaceuticals Limited	20260519
8f3e9739-8ec1-4ea9-b1bc-185fd07d84e4	These 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: 2012	Alembic Pharmaceuticals Limited	20260519

Drug Classes#

Source, Class ID, Class table
Source	Class ID	Class	Type	Relationship	Drug concept
ATC	L01EA	BCR-ABL tyrosine kinase inhibitors	ATC1-4		bosutinib
FDASPL	N0000175605	Kinase Inhibitor	EPC	has_epc	bosutinib
FDASPL	N0000020009	Bcr-Abl Tyrosine Kinase Inhibitors	MOA	has_moa	bosutinib
MEDRT	D000814	Aniline Compounds	CHEM	has_ingredient	bosutinib
MEDRT	D009570	Nitriles	CHEM	has_ingredient	bosutinib
MEDRT	D011804	Quinolines	CHEM	has_ingredient	bosutinib
MEDRT	D004342	Drug Hypersensitivity	DISEASE	ci_with	bosutinib
MEDRT	D015464	Leukemia, Myelogenous, Chronic, BCR-ABL Positive	DISEASE	may_treat	bosutinib
MEDRT	N0000020001	Tyrosine Kinase Inhibitors	MOA	has_moa	bosutinib
MEDRT	N0000175672	Cellular Proliferation Alteration	PE	has_pe	bosutinib

Group, Type, Concept table
Group	Type	Concept	Source
BN	BN	Bosulif	rxnav_allrelated
DF	DF	Oral Tablet	rxnav_allrelated
DFG	DFG	Oral Product	rxnav_allrelated
DFG	DFG	Pill	rxnav_allrelated
IN	IN	bosutinib	rxnav_allrelated
SBD	SBD	bosutinib 500 MG Oral Tablet [Bosulif]	rxnav_allrelated
SBDC	SBDC	bosutinib 500 MG [Bosulif]	rxnav_allrelated
SBDF	SBDF	bosutinib Oral Tablet [Bosulif]	rxnav_allrelated
SBDG	SBDG	Bosulif Oral Product	rxnav_allrelated
SBDG	SBDG	Bosulif Pill	rxnav_allrelated
SCD	SCD	bosutinib 500 MG Oral Tablet	rxnav_allrelated
SCDC	SCDC	bosutinib 500 MG	rxnav_allrelated
SCDF	SCDF	bosutinib Oral Tablet	rxnav_allrelated
SCDG	SCDG	bosutinib Oral Product	rxnav_allrelated
SCDG	SCDG	bosutinib Pill	rxnav_allrelated

Properties#

Category, Property, Value table
Category	Property	Value
ATTRIBUTES	AVAILABLE_STRENGTH	500 MG
ATTRIBUTES	GENERAL_CARDINALITY	SINGLE
ATTRIBUTES	HUMAN_DRUG	US
ATTRIBUTES	RXNAV_HUMAN_DRUG	US
ATTRIBUTES	SCHEDULE	0
CODES	ANDA	ANDA209543
CODES	SNOMEDCT	1145411008
CODES	VUID	4031693
NAMES	Prescribable Synonym	bosutinib 500 MG Oral Tablet
SOURCES	Source	Metathesaurus FDA Structured Product Labels
SOURCES	Source	Micromedex RED BOOK
SOURCES	Source	Multum MediSource Lexicon
SOURCES	Source	National Drug Data File Plus Source Vocabulary
SOURCES	Source	US Edition of SNOMED_CT
SOURCES	Source	Veterans Health Administration National Drug File