NDC 63539-117

BOSULIF

Bosutinib

BOSULIF is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by U.s. Pharmaceuticals. The primary component is Bosutinib Monohydrate.

• Product ID: 63539-117_36db594d-78c5-4535-8b8f-0ee0ec2e010f
• NDC: 63539-117
• Product Type: Human Prescription Drug
• Proprietary Name: BOSULIF
• Generic Name: Bosutinib
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2012-09-04
• Marketing Category: NDA / NDA
• Application Number: NDA203341
• Labeler Name: U.S. Pharmaceuticals
• Substance Name: BOSUTINIB MONOHYDRATE
• Active Ingredient Strength: 100 mg/1
• Pharm Classes: Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Kinase Inhibitor [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 63539-117-01

120 TABLET, FILM COATED in 1 BOTTLE (63539-117-01)

• Marketing Start Date: 2012-09-04
• NDC Exclude Flag: N
• Sample Package?: Y

NDC SPL Data Element Entries

NDC 63539-117-01 [63539011701]

BOSULIF TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA203341
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2012-09-04

Drug Details

Active Ingredients

Ingredient	Strength
BOSUTINIB MONOHYDRATE	100 mg/1

OpenFDA Data

• SPL SET ID: d5929f91-6496-4c0e-97e8-0bd524e15763
• Manufacturer:
  • U.S. Pharmaceuticals
• UNII:
  • 844ZJE6I55
• RxNorm Concept Unique ID - RxCUI:
  • 1307630
  • 1307624

Pharmacological Class

• Kinase Inhibitor [EPC]
• Protein Kinase Inhibitors [MoA]
• P-Glycoprotein Inhibitors [MoA]

NDC Crossover Matching brand name "BOSULIF" or generic name "Bosutinib"

NDC	Brand Name	Generic Name
0069-0135	BOSULIF	Bosutinib monohydrate
0069-0136	BOSULIF	Bosutinib monohydrate
0069-0193	BOSULIF	Bosutinib monohydrate
63539-117	BOSULIF	Bosutinib
63539-193	BOSULIF	Bosutinib