Prescription drug · NDA
Alunbrig (Brigatinib) NDC 63020-198
Kit · Takeda Pharmaceuticals America, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63020-198-30 | 6302001983063020019830 | 1 KIT in 1 CARTON (63020-198-30) * 7 TABLET, FILM COATED in 1 BOTTLE (63020-090-07) * 23 TABLET, FILM COATED in 1 BOTTLE (63020-180-23)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
- Dosage form
- Kit
- Labeler
- Takeda Pharmaceuticals America, Inc.NDC labeler code 63020
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 208772
- Marketing start
- Listing expires
- Identifiers
- Product ID 63020-198_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
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N463020019830followed by a unit qualifier and the quantityPackage 63020-0198-30. 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.
About NDC 63020-198
- What is NDC 63020-198?
- 63020-198 is the product NDC for Alunbrig (brigatinib) kit, listed with the FDA by Takeda Pharmaceuticals America, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Alunbrig (Brigatinib).
- Who is the labeler?
- Takeda Pharmaceuticals America, Inc., NDC labeler code 63020. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Alunbrig?
- 3 other product NDCs are listed under this name. See all Alunbrig NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Alunbrig products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Alunbrigbrigatinib | Brigatinib 90 mg/1 | Tablet, Film coatedOral | Takeda Pharmaceuticals America, Inc. | 63020-090 | 63020-0090-0763020-0090-30 |
| Alunbrigbrigatinib | Brigatinib 30 mg/1 | Tablet, Film coatedOral | Takeda Pharmaceuticals America, Inc. | 63020-113 | 63020-0113-30 |
| Alunbrigbrigatinib | Brigatinib 180 mg/1 | Tablet, Film coatedOral | Takeda Pharmaceuticals America, Inc. | 63020-180 | 63020-0180-30 |
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 | Brigatinib 90 mg/1 | Tablet, Film coatedOral | Takeda Pharmaceuticals America, Inc. | 63020-090 |
| Alunbrigbrigatinib | Brigatinib 30 mg/1 | Tablet, Film coatedOral | Takeda Pharmaceuticals America, Inc. | 63020-113 |
| Alunbrigbrigatinib | Brigatinib 180 mg/1 | Tablet, Film coatedOral | Takeda Pharmaceuticals America, Inc. | 63020-180 |