Search by Drug Name or NDC
NDC 00069-0507-60 Xalkori 50 mg/1 Details
Xalkori 50 mg/1
Xalkori is a ORAL CAPSULE, COATED PELLETS in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Pfizer Laboratories Div Pfizer Inc. The primary component is CRIZOTINIB.
MedlinePlus Drug Summary
Crizotinib is used to treat certain types of non-small cell lung cancer (NSCLC) that has spread to nearby tissues or to other parts of the body. It is also used to treat a certain type of anaplastic large cell lymphoma (ALCL) that has returned or is unresponsive to other treatment(s) in certain adults and children 1 year of age and older. Crizotinib is also used to treat a certain type of inflammatory myofibroblastic tumor (IMT; type of cancer that occurs in mucosal tissues usually in the abdominal area, involving the lungs, bladder, stomach, uterus, liver, or intestines) that cannot be treated with surgery or that has not improved or has come back after previous treatment(s) in adults and children 1 year of age and older. Crizotinib is in a class of medications called kinase inhibitors. It works by blocking the action of a certain naturally occurring substance that may be needed to help cancer cells multiply.
Related Packages: 00069-0507-60Last Updated: 03/24/2024
MedLinePlus Full Drug Details: Crizotinib
Product Information
| NDC | 00069-0507 |
|---|---|
| Product ID | 0069-0507_e4384d2f-d204-468c-a2d4-23666e3a493f |
| Associated GPIs | |
| GCN Sequence Number | 085523 |
| GCN Sequence Number Description | crizotinib PEL DSP CP 50 MG ORAL |
| HIC3 | V1Q |
| HIC3 Description | ANTINEOPLASTIC SYSTEMIC ENZYME INHIBITORS |
| GCN | 55028 |
| HICL Sequence Number | 037916 |
| HICL Sequence Number Description | CRIZOTINIB |
| Brand/Generic | Brand |
| Proprietary Name | Xalkori |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | CRIZOTINIB |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE, COATED PELLETS |
| Route | ORAL |
| Active Ingredient Strength | 50 |
| Active Ingredient Units | mg/1 |
| Substance Name | CRIZOTINIB |
| Labeler Name | Pfizer Laboratories Div Pfizer Inc |
| Pharmaceutical 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 Inhi |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA217581 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00069-0507-60 (00069050760)
| NDC Package Code | 0069-0507-60 |
|---|---|
| Billing NDC | 00069050760 |
| Package | 60 CAPSULE, COATED PELLETS in 1 BOTTLE (0069-0507-60) |
| Marketing Start Date | 2023-11-20 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |