NDC 0069-8140

Xalkori

Crizotinib

Xalkori is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Pfizer Laboratories Div Pfizer Inc. The primary component is Crizotinib.

• Product ID: 0069-8140_19c4d302-9bf2-4557-8f22-f2c94341fd1a
• NDC: 0069-8140
• Product Type: Human Prescription Drug
• Proprietary Name: Xalkori
• Generic Name: Crizotinib
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2011-08-26
• Marketing Category: NDA / NDA
• Application Number: NDA202570
• Labeler Name: Pfizer Laboratories Div Pfizer Inc
• Substance Name: CRIZOTINIB
• Active Ingredient Strength: 250 mg/1
• Pharm Classes: Kinase Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Receptor Tyrosine Kinase Inhibitors [MoA],Cytochrome P450 2B6 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Organic Cation Transporter 1 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0069-8140-20

60 CAPSULE in 1 BOTTLE (0069-8140-20)

• Marketing Start Date: 2011-08-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0069-8140-20 [00069814020]

Xalkori CAPSULE

• Marketing Category: NDA
• Application Number: NDA202570
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-08-26

Drug Details

Active Ingredients

Ingredient	Strength
CRIZOTINIB	250 mg/1

OpenFDA Data

• SPL SET ID: 2a51b0de-47d6-455e-a94c-d2c737b04ff7
• Manufacturer:
  • Pfizer Laboratories Div Pfizer Inc
• UNII:
  • 53AH36668S
• RxNorm Concept Unique ID - RxCUI:
  • 1148502
  • 1148504
  • 1148506
  • 1148498
• UPC Code:
  • 0300698140201
  • 0300698141208

Pharmacological Class

• Kinase Inhibitor [EPC]
• Cytochrome P450 3A Inhibitors [MoA]
• Receptor Tyrosine Kinase Inhibitors [MoA]
• Cytochrome P450 2B6 Inhibitors [MoA]
• P-Glycoprotein Inhibitors [MoA]
• Organic Cation Transporter 1 Inhibitors [MoA]
• Organic Cation Transporter 2 Inhibitors [MoA]

NDC Crossover Matching brand name "Xalkori" or generic name "Crizotinib"

NDC	Brand Name	Generic Name
0069-8140	Xalkori	CRIZOTINIB
0069-8141	Xalkori	CRIZOTINIB