Prescription drug · NDA
Lorbrena (Lorlatinib) NDC 63539-927
Lorlatinib 25 mg/1 · Tablet, Film coated · Oral · U.S. Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63539-927-01 | 63539092701 | 30 TABLET, FILM COATED in 1 BOTTLE (63539-927-01)Marketed from Jan 3, 2023 · Sample package |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Lorbrena
- Generic name (nonproprietary)
- lorlatinib
- Active ingredients
- Lorlatinib — 25 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- U.S. PharmaceuticalsNDC labeler code 63539
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 210868
- Marketing start
- Listing expires
- Other FDA classes
- Breast Cancer Resistance Protein Inhibitors (Mechanism)Cytochrome P450 2B6 Inducers (Mechanism)Cytochrome P450 3A Inducers (Mechanism)Kinase Inhibitors (Mechanism)Multidrug and Toxin Extrusion Transporter 1 Inhibitors (Mechanism)Organic Anion Transporter 3 Inhibitors (Mechanism)Organic Cation Transporter 1 Inhibitors (Mechanism)P-Glycoprotein Inducers (Mechanism)
- Identifiers
- Product ID 63539-927_810ce789-bff1-42b9-aef7-1f92f0dde727SPL ID 810ce789-bff1-42b9-aef7-1f92f0dde727SPL set ID 004f93d7-a1cd-4b67-9207-31cdcb5c5976RxCUI 2103169, 2103175UNII OSP71S83EU
- 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
N463539092701followed by a unit qualifier and the quantityPackage 63539-0927-01. 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)
LORBRENA ® is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. LORBRENA 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)-positive as detected by an FDA-approved test. ( 1 , 2.1 )
Excerpt only. Read the full label for complete information.
About NDC 63539-927
- What is NDC 63539-927?
- 63539-927 is the product NDC for Lorbrena (lorlatinib), Lorlatinib 25 mg/1 tablet, film coated, listed with the FDA by U.S. Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lorbrena (Lorlatinib).
- What is the active ingredient?
- Lorlatinib.
- Who is the labeler?
- U.S. Pharmaceuticals, NDC labeler code 63539. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lorbrena?
- 2 other product NDCs are listed under this name. See all Lorbrena NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lorbrena products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lorbrenalorlatinib | Lorlatinib 25 mg/1 | Tablet, Film coatedOral | Pfizer Laboratories Div Pfizer Inc | 0069-0227 | 00069-0227-0100069-0227-03 |
| Lorbrenalorlatinib | Lorlatinib 100 mg/1 | Tablet, Film coatedOral | Pfizer Laboratories Div Pfizer Inc | 0069-0231 | 00069-0231-01 |
Other NDCs under NDA 210868
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 |
|---|---|---|---|---|
| Lorbrenalorlatinib | Lorlatinib 25 mg/1 | Tablet, Film coatedOral | Pfizer Laboratories Div Pfizer Inc | 0069-0227 |
| Lorbrenalorlatinib | Lorlatinib 100 mg/1 | Tablet, Film coatedOral | Pfizer Laboratories Div Pfizer Inc | 0069-0231 |