Prescription drug · NDA
Xalkori (Crizotinib) NDC 0069-0251
Crizotinib 20 mg/1 · Capsule, Coated pellets · Oral · Pfizer Laboratories Div Pfizer Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0069-0251-60 | 00069025160 | 60 CAPSULE, COATED PELLETS in 1 BOTTLE (0069-0251-60)Marketed from Nov 20, 2023 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Xalkori
- Generic name (nonproprietary)
- crizotinib
- Active ingredients
- Crizotinib — 20 mg/1
- Dosage form
- Capsule, Coated pellets
- Route
- Oral
- Labeler
- Pfizer Laboratories Div Pfizer IncNDC labeler code 0069
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 217581
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2B6 Inhibitors (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Organic Cation Transporter 1 Inhibitors (Mechanism)Organic Cation Transporter 2 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)Receptor Tyrosine Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 0069-0251_f5e01d3a-43fc-4fa6-b5dd-a07330b49328SPL ID f5e01d3a-43fc-4fa6-b5dd-a07330b49328SPL set ID 2a51b0de-47d6-455e-a94c-d2c737b04ff7RxCUI 1148498, 1148502, 1148504, 1148506, 2670166, 2670170, 2670172, 2670174, 2670176, 2670178UNII 53AH36668SUPC 0300698140201, 0300690507606, 0300690251608, 0300691500606, 0300698141208
- Pharmacologic class
- Kinase Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400069025160followed by a unit qualifier and the quantityPackage 00069-0251-60. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
XALKORI is a kinase inhibitor indicated for the treatment of • adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK) or ROS1-positive as detected by an FDA-approved test. ( 1.1 , 2.1 ) • pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive. ( 1.2 , 2.3 ) o Limitations of Use: The safety and efficacy of XALKORI have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL. • adult and pediatric patients 1 year of age and older with unresectable, recurrent, or refractory inflammatory myofibrobla…
Excerpt only. Read the full label for complete information.
About NDC 0069-0251
- What is NDC 0069-0251?
- 0069-0251 is the product NDC for Xalkori (crizotinib), Crizotinib 20 mg/1 capsule, coated pellets, listed with the FDA by Pfizer Laboratories Div Pfizer Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Xalkori (Crizotinib).
- What is the active ingredient?
- Crizotinib.
- Who is the labeler?
- Pfizer Laboratories Div Pfizer Inc, NDC labeler code 0069. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Xalkori?
- 4 other product NDCs are listed under this name. See all Xalkori NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Xalkori products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Xalkoricrizotinib | Crizotinib 150 mg/1 | Capsule, Coated pelletsOral | Pfizer Laboratories Div Pfizer Inc | 0069-1500 | 00069-1500-60 |
| Xalkoricrizotinib | Crizotinib 50 mg/1 | Capsule, Coated pelletsOral | Pfizer Laboratories Div Pfizer Inc | 0069-0507 | 00069-0507-60 |
| Xalkoricrizotinib | Crizotinib 250 mg/1 | CapsuleOral | Pfizer Laboratories Div Pfizer Inc | 0069-8140 | 00069-8140-20 |
| Xalkoricrizotinib | Crizotinib 200 mg/1 | CapsuleOral | Pfizer Laboratories Div Pfizer Inc | 0069-8141 | 00069-8141-20 |
Other NDCs under NDA 217581
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Xalkoricrizotinib | Crizotinib 150 mg/1 | Capsule, Coated pelletsOral | Pfizer Laboratories Div Pfizer Inc | 0069-1500 |
| Xalkoricrizotinib | Crizotinib 50 mg/1 | Capsule, Coated pelletsOral | Pfizer Laboratories Div Pfizer Inc | 0069-0507 |