NDC 0069-0193

BOSULIF

Bosutinib Monohydrate

BOSULIF is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Pfizer Laboratories Div Pfizer Inc. The primary component is Bosutinib Monohydrate.

• Product ID: 0069-0193_28ccd2f3-a7b1-44fa-8dab-cb6a88fffd27
• NDC: 0069-0193
• Product Type: Human Prescription Drug
• Proprietary Name: BOSULIF
• Generic Name: Bosutinib Monohydrate
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2017-12-18
• Marketing Category: NDA / NDA
• Application Number: NDA203341
• Labeler Name: Pfizer Laboratories Div Pfizer Inc
• Substance Name: BOSUTINIB MONOHYDRATE
• Active Ingredient Strength: 400 mg/1
• Pharm Classes: Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0069-0193-01

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

• Marketing Start Date: 2017-12-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0069-0193-01 [00069019301]

BOSULIF TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA203341
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-12-18

Drug Details

Active Ingredients

Ingredient	Strength
BOSUTINIB MONOHYDRATE	400 mg/1

OpenFDA Data

• SPL SET ID: adc84ad5-a04d-4fee-9ba8-91f7abd928e3
• Manufacturer:
  • Pfizer Laboratories Div Pfizer Inc
• UNII:
  • 844ZJE6I55
• RxNorm Concept Unique ID - RxCUI:
  • 1307624
  • 1987732
  • 1987734
  • 1307630
  • 1307633
  • 1307635
• UPC Code:
  • 0300690193014
  • 0300690136011
  • 0300690135014

Pharmacological Class

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

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

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