Xalkori
- Product NDC
- 0069-1500
- 11-digit product format
- 000691500
- Labeler code
- 0069
- Product ID
- 0069-1500_f5e01d3a-43fc-4fa6-b5dd-a07330b49328
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- CRIZOTINIB
- Dosage form
- CAPSULE, COATED PELLETS
- Route
- ORAL
- Labeler
- Pfizer Laboratories Div Pfizer Inc
- Application
- NDA217581
- Marketing category
- NDA
- Marketing start
- 2023-11-20
- Substance
- CRIZOTINIB
- Active strength
- 150 mg/1
- Pharmacologic classes
- 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]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 53AH36668S | CRIZOTINIB | 877399-52-5 | CRIZOTINIB |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0069-1500-60 | 00069150060 | 60 CAPSULE, COATED PELLETS in 1 BOTTLE (0069-1500-60) | 2023-11-20 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Xalkori | Pfizer Laboratories Div Pfizer Inc | Pfizer Inc | Pfizer Ireland Pharmaceuticals Unlimited Company | Pfizer Manufacturing Deutschland GmbH | Upjohn Manufacturing Ireland Unlimited Company | Pfizer Asia Manufacturing Pte Ltd | 2025-07-22 | HUMAN PRESCRIPTION DRUG LABEL | 46 |