Prescription drug · NDA
Alunbrig (brigatinib) NDC 63020-113
Brigatinib 30 mg/1 · Tablet, Film coated · Oral · Takeda Pharmaceuticals America, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63020-113-30 | 63020011330 | 30 TABLET, FILM COATED in 1 BOTTLE (63020-113-30)Marketed from Oct 2, 2017 |
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)
- Alunbrig
- Generic name (nonproprietary)
- brigatinib
- Active ingredients
- Brigatinib — 30 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 208772
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 3A Inducers (Mechanism)Tyrosine Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 63020-113_176eb255-05c0-4cfc-874f-1fb57136d34dSPL ID 176eb255-05c0-4cfc-874f-1fb57136d34dSPL set ID 0fe9ff20-d402-41f3-bc1e-7002ea7007dbRxCUI 1921222, 1921228, 1925494, 1988768, 1988770, 1988772, 1988785, 1988786UNII HYW8DB273J
- 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
N463020011330followed by a unit qualifier and the quantityPackage 63020-0113-30. 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)
ALUNBRIG is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test [see Dosage and Administration (2.1) ] . ALUNBRIG is a kinase inhibitor indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. ( 1 , 2.1 )
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 208772
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 |
|---|---|---|---|---|
| Alunbrigbrigatinib | — | Kit | Takeda Pharmaceuticals America, Inc. | 63020-198 |
| Alunbrigbrigatinib | Brigatinib 90 mg/1 | Tablet, Film coatedOral | Takeda Pharmaceuticals America, Inc. | 63020-090 |
| Alunbrigbrigatinib | Brigatinib 180 mg/1 | Tablet, Film coatedOral | Takeda Pharmaceuticals America, Inc. | 63020-180 |