bosulif

Generic: bosutinib

Labeler: pfizer laboratories div pfizer inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name bosulif
Generic Name bosutinib
Labeler pfizer laboratories div pfizer inc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

bosutinib monohydrate 400 mg/1

Manufacturer
Pfizer Laboratories Div Pfizer Inc

Identifiers & Regulatory

Product NDC 0069-0193
Product ID 0069-0193_ca8600d9-46e6-402d-89f9-bc6a156bf751
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA203341
Listing Expiration 2027-12-31
Marketing Start 2017-12-18

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00690193
Hyphenated Format 0069-0193

Supplemental Identifiers

UPC
0300691014158 0300690504308 0300690193014 0300690136011 0300690135014
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 (0069-0193-01)
source: ndc

Packages (1)

0069-0193-01 30 TABLET, FILM COATED in 1 BOTTLE (0069-0193-01)

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": "ca8600d9-46e6-402d-89f9-bc6a156bf751", "openfda": {"upc": ["0300691014158", "0300690504308", "0300690193014", "0300690136011", "0300690135014"], "unii": ["844ZJE6I55"], "spl_set_id": ["adc84ad5-a04d-4fee-9ba8-91f7abd928e3"], "manufacturer_name": ["Pfizer Laboratories Div Pfizer Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (0069-0193-01)", "package_ndc": "0069-0193-01", "marketing_start_date": "20171218"}], "brand_name": "BOSULIF", "product_id": "0069-0193_ca8600d9-46e6-402d-89f9-bc6a156bf751", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Bcr-Abl Tyrosine Kinase Inhibitors [MoA]", "Kinase Inhibitor [EPC]"], "product_ndc": "0069-0193", "generic_name": "Bosutinib", "labeler_name": "Pfizer Laboratories Div Pfizer Inc", "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": "20171218", "listing_expiration_date": "20271231"}