FDA.reportPublic FDA data

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

Additional Listing Data#

Finished product
Yes
Brand name base
BOSULIF
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BOSUTINIB MONOHYDRATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii844ZJE6I55
Rxcui1307624, 1307630, 1307633, 1307635, 1987732, 1987734, 2669663, 2669665, 2672326, 2672328

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b80921c3-d121-9271-9cc7-bf0fa96ea081Product name320260309
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0069-1014-15BOSULIF150 in 1 BOTTLECAPSULE15032

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0069-1014-15EA - Each0069-10142a497ba9-1134-43f1-9a7e-77f330a672ba12024-02-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BOSUTINIB MONOHYDRATEACTIVE INGREDIENT844ZJE6I55BOSULIF (BOSUTINIB MONOHYDRATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]8
BOSUTINIBACTIVE MOIETY5018V4AEZ0BOSULIF (BOSUTINIB MONOHYDRATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBOSULIF (BOSUTINIB MONOHYDRATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]8
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48BOSULIF (BOSUTINIB MONOHYDRATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]8
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675BOSULIF (BOSUTINIB MONOHYDRATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]8
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTBOSULIF (BOSUTINIB MONOHYDRATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BOSULIF (BOSUTINIB MONOHYDRATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]8
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGBOSULIF (BOSUTINIB MONOHYDRATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]8
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PBOSULIF (BOSUTINIB MONOHYDRATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]8
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990BOSULIF (BOSUTINIB MONOHYDRATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]8
POVIDONE K25INACTIVE INGREDIENTK0KQV10C35BOSULIF (BOSUTINIB MONOHYDRATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]8
TALCINACTIVE INGREDIENT7SEV7J4R1UBOSULIF (BOSUTINIB MONOHYDRATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBOSULIF (BOSUTINIB MONOHYDRATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0069-1014BOSULIF (BOSUTINIB) TABLET, FILM COATED BOSULIF (BOSUTINIB) CAPSULE [PFIZER LABORATORIES DIV PFIZER INC]31Current NDC, 1 package rows20241215_adc84ad5-a04d-4fee-9ba8-91f7abd928e3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2672326Bosulif 100 MG Oral CapsulePSNadc84ad5-a04d-4fee-9ba8-91f7abd928e332
1307630Bosulif 100 MG Oral TabletPSNadc84ad5-a04d-4fee-9ba8-91f7abd928e332
1987734Bosulif 400 MG Oral TabletPSNadc84ad5-a04d-4fee-9ba8-91f7abd928e332
2672328Bosulif 50 MG Oral CapsulePSNadc84ad5-a04d-4fee-9ba8-91f7abd928e332
1307635Bosulif 500 MG Oral TabletPSNadc84ad5-a04d-4fee-9ba8-91f7abd928e332
2669663bosutinib 100 MG Oral CapsulePSNadc84ad5-a04d-4fee-9ba8-91f7abd928e332
1307624bosutinib 100 MG Oral TabletPSNadc84ad5-a04d-4fee-9ba8-91f7abd928e332
1987732bosutinib 400 MG Oral TabletPSNadc84ad5-a04d-4fee-9ba8-91f7abd928e332
2669665bosutinib 50 MG Oral CapsulePSNadc84ad5-a04d-4fee-9ba8-91f7abd928e332
1307633bosutinib 500 MG Oral TabletPSNadc84ad5-a04d-4fee-9ba8-91f7abd928e332
2672326bosutinib 100 MG Oral Capsule [Bosulif]SBDadc84ad5-a04d-4fee-9ba8-91f7abd928e332
1307630bosutinib 100 MG Oral Tablet [Bosulif]SBDadc84ad5-a04d-4fee-9ba8-91f7abd928e332
1987734bosutinib 400 MG Oral Tablet [Bosulif]SBDadc84ad5-a04d-4fee-9ba8-91f7abd928e332
2672328bosutinib 50 MG Oral Capsule [Bosulif]SBDadc84ad5-a04d-4fee-9ba8-91f7abd928e332
1307635bosutinib 500 MG Oral Tablet [Bosulif]SBDadc84ad5-a04d-4fee-9ba8-91f7abd928e332
2669663bosutinib 100 MG Oral CapsuleSCDadc84ad5-a04d-4fee-9ba8-91f7abd928e332
1307624bosutinib 100 MG Oral TabletSCDadc84ad5-a04d-4fee-9ba8-91f7abd928e332
1987732bosutinib 400 MG Oral TabletSCDadc84ad5-a04d-4fee-9ba8-91f7abd928e332
2669665bosutinib 50 MG Oral CapsuleSCDadc84ad5-a04d-4fee-9ba8-91f7abd928e332
1307633bosutinib 500 MG Oral TabletSCDadc84ad5-a04d-4fee-9ba8-91f7abd928e332
1307630Bosulif 100 MG (as bosutinib monohydrate 103.4 MG) Oral TabletSYadc84ad5-a04d-4fee-9ba8-91f7abd928e332
2672326Bosulif 100 MG Oral CapsuleSYadc84ad5-a04d-4fee-9ba8-91f7abd928e332
1307630Bosulif 100 MG Oral TabletSYadc84ad5-a04d-4fee-9ba8-91f7abd928e332
1987734Bosulif 400 MG (as bosutinib monohydrate 413.6 MG) Oral TabletSYadc84ad5-a04d-4fee-9ba8-91f7abd928e332
1987734Bosulif 400 MG Oral TabletSYadc84ad5-a04d-4fee-9ba8-91f7abd928e332
2672328Bosulif 50 MG Oral CapsuleSYadc84ad5-a04d-4fee-9ba8-91f7abd928e332
1307635Bosulif 500 MG (as bosutinib monohydrate 516.98 MG) Oral TabletSYadc84ad5-a04d-4fee-9ba8-91f7abd928e332
1307635Bosulif 500 MG Oral TabletSYadc84ad5-a04d-4fee-9ba8-91f7abd928e332
1307624bosutinib 100 MG (as bosutinib monohydrate 103.4 MG) Oral TabletSYadc84ad5-a04d-4fee-9ba8-91f7abd928e332
1987732bosutinib 400 MG (as bosutinib monohydrate 413.6 MG) Oral TabletSYadc84ad5-a04d-4fee-9ba8-91f7abd928e332
1307633bosutinib 500 MG (as bosutinib monohydrate 516.98 MG) Oral TabletSYadc84ad5-a04d-4fee-9ba8-91f7abd928e332

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0069-1014-1500069101415150 CAPSULE in 1 BOTTLE (0069-1014-15) 150 capsule2024-01-02NoNoCurrent