xalkori

Generic: crizotinib

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

Drug Facts

Product Profile

Brand Name xalkori
Generic Name crizotinib
Labeler pfizer laboratories div pfizer inc
Dosage Form CAPSULE, COATED PELLETS
Routes
ORAL
Active Ingredients

crizotinib 20 mg/1

Manufacturer
Pfizer Laboratories Div Pfizer Inc

Identifiers & Regulatory

Product NDC 0069-0251
Product ID 0069-0251_f5e01d3a-43fc-4fa6-b5dd-a07330b49328
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA217581
Listing Expiration 2026-12-31
Marketing Start 2023-11-20

Pharmacologic Class

Established (EPC)
kinase inhibitor [epc]
Mechanism of Action
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]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00690251
Hyphenated Format 0069-0251

Supplemental Identifiers

RxCUI
1148498 1148502 1148504 1148506 2670166 2670170 2670172 2670174 2670176 2670178
UPC
0300698140201 0300690507606 0300690251608 0300691500606 0300698141208
UNII
53AH36668S
NUI
N0000175605 N0000190114 N0000020000 N0000182139 N0000185503 N0000191265 N0000187061

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 xalkori (source: ndc)
Generic Name crizotinib (source: ndc)
Application Number NDA217581 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 60 CAPSULE, COATED PELLETS in 1 BOTTLE (0069-0251-60)
source: ndc

Packages (1)

0069-0251-60 60 CAPSULE, COATED PELLETS in 1 BOTTLE (0069-0251-60)

Ingredients (1)

crizotinib (20 mg/1)

Linked Drug Pages (1)

Xalkori ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f5e01d3a-43fc-4fa6-b5dd-a07330b49328", "openfda": {"nui": ["N0000175605", "N0000190114", "N0000020000", "N0000182139", "N0000185503", "N0000191265", "N0000187061"], "upc": ["0300698140201", "0300690507606", "0300690251608", "0300691500606", "0300698141208"], "unii": ["53AH36668S"], "rxcui": ["1148498", "1148502", "1148504", "1148506", "2670166", "2670170", "2670172", "2670174", "2670176", "2670178"], "spl_set_id": ["2a51b0de-47d6-455e-a94c-d2c737b04ff7"], "pharm_class_epc": ["Kinase Inhibitor [EPC]"], "pharm_class_moa": ["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]"], "manufacturer_name": ["Pfizer Laboratories Div Pfizer Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE, COATED PELLETS in 1 BOTTLE (0069-0251-60)", "package_ndc": "0069-0251-60", "marketing_start_date": "20231120"}], "brand_name": "Xalkori", "product_id": "0069-0251_f5e01d3a-43fc-4fa6-b5dd-a07330b49328", "dosage_form": "CAPSULE, COATED PELLETS", "pharm_class": ["Cytochrome P450 2B6 Inhibitors [MoA]", "Cytochrome P450 3A Inhibitors [MoA]", "Kinase Inhibitor [EPC]", "Organic Cation Transporter 1 Inhibitors [MoA]", "Organic Cation Transporter 2 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]", "Receptor Tyrosine Kinase Inhibitors [MoA]"], "product_ndc": "0069-0251", "generic_name": "CRIZOTINIB", "labeler_name": "Pfizer Laboratories Div Pfizer Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Xalkori", "active_ingredients": [{"name": "CRIZOTINIB", "strength": "20 mg/1"}], "application_number": "NDA217581", "marketing_category": "NDA", "marketing_start_date": "20231120", "listing_expiration_date": "20261231"}