bosulif

Generic: bosutinib

Labeler: u.s. pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name bosulif
Generic Name bosutinib
Labeler u.s. pharmaceuticals
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

bosutinib monohydrate 400 mg/1

Manufacturer
U.S. Pharmaceuticals

Identifiers & Regulatory

Product NDC 63539-193
Product ID 63539-193_936ca777-7c42-4d88-a084-002df2b95f1c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA203341
Listing Expiration 2026-12-31
Marketing Start 2012-09-04

Pharmacologic Class

Classes
bcr-abl tyrosine kinase inhibitors [moa] kinase inhibitor [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63539193
Hyphenated Format 63539-193

Supplemental Identifiers

RxCUI
1307624 1307630 1987732 1987734
UNII
844ZJE6I55

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name bosulif (source: ndc)
Generic Name bosutinib (source: ndc)
Application Number NDA203341 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (63539-193-30)
source: ndc

Packages (1)

63539-193-30 30 TABLET, FILM COATED in 1 BOTTLE (63539-193-30)

Ingredients (1)

bosutinib monohydrate (400 mg/1)

Linked Drug Pages (1)

BOSULIF ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "936ca777-7c42-4d88-a084-002df2b95f1c", "openfda": {"unii": ["844ZJE6I55"], "rxcui": ["1307624", "1307630", "1987732", "1987734"], "spl_set_id": ["d5929f91-6496-4c0e-97e8-0bd524e15763"], "manufacturer_name": ["U.S. Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (63539-193-30)", "package_ndc": "63539-193-30", "marketing_start_date": "20180221"}], "brand_name": "BOSULIF", "product_id": "63539-193_936ca777-7c42-4d88-a084-002df2b95f1c", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Bcr-Abl Tyrosine Kinase Inhibitors [MoA]", "Kinase Inhibitor [EPC]"], "product_ndc": "63539-193", "generic_name": "Bosutinib", "labeler_name": "U.S. Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BOSULIF", "active_ingredients": [{"name": "BOSUTINIB MONOHYDRATE", "strength": "400 mg/1"}], "application_number": "NDA203341", "marketing_category": "NDA", "marketing_start_date": "20120904", "listing_expiration_date": "20261231"}