Xalkori
- Product NDC
- 0069-0251
- 11-digit product format
- 000690251
- Labeler code
- 0069
- Product ID
- 0069-0251_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
- 20 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Xalkori
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CRIZOTINIB | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 53AH36668S |
| Rxcui | 1148498, 1148502, 1148504, 1148506, 2670166, 2670170, 2670172, 2670174, 2670176, 2670178 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0069-0251-60 | Xalkori | 60 in 1 BOTTLE | CAPSULE, COATED PELLETS | 60 | | 46 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0069-0251 | XALKORI (CRIZOTINIB) CAPSULE XALKORI (CRIZOTINIB) CAPSULE, COATED PELLETS [PFIZER LABORATORIES DIV PFIZER INC] | 45 | Current NDC, 1 package rows | 20250109_2a51b0de-47d6-455e-a94c-d2c737b04ff7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0069-0251-60 | 00069025160 | 60 CAPSULE, COATED PELLETS in 1 BOTTLE (0069-0251-60) | 2023-11-20 | No | No | Current |