NDC 63020-113
Alunbrig
Brigatinib
Alunbrig is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Takeda Pharmaceuticals America, Inc.. The primary component is Brigatinib.
| Product ID | 63020-113_016a4a8c-c47c-49a2-b38f-439eebc4c466 |
| NDC | 63020-113 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Alunbrig |
| Generic Name | Brigatinib |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2017-04-28 |
| Marketing Category | NDA / NDA |
| Application Number | NDA208772 |
| Labeler Name | Takeda Pharmaceuticals America, Inc. |
| Substance Name | BRIGATINIB |
| Active Ingredient Strength | 30 mg/1 |
| Pharm Classes | Cytochrome P450 3A Inducers [MoA], Kinase Inhibitor [EPC], Tyrosine Kinase Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
Packaging
NDC 63020-113-18
180 TABLET, FILM COATED in 1 BOTTLE (63020-113-18)
| Marketing Start Date | 2017-10-02 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 63020-113-18 [63020011318]
Alunbrig TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA208772 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-10-02 |
NDC 63020-113-21 [63020011321]
Alunbrig TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA208772 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-10-02 |
NDC 63020-113-30 [63020011330]
Alunbrig TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA208772 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2017-10-02 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| BRIGATINIB | 30 mg/1 |
OpenFDA Data
| SPL SET ID: | 0fe9ff20-d402-41f3-bc1e-7002ea7007db |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Kinase Inhibitor [EPC]
- Tyrosine Kinase Inhibitors [MoA]
- Cytochrome P450 3A Inducers [MoA]
NDC Crossover Matching brand name "Alunbrig" or generic name "Brigatinib"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 63020-090 | Alunbrig | brigatinib |
| 63020-113 | Alunbrig | brigatinib |
| 63020-180 | Alunbrig | brigatinib |
| 63020-198 | Alunbrig | brigatinib |
| 76189-113 | Alunbrig | Brigatinib |
Trademark Results [Alunbrig]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ALUNBRIG 86797024 5251769 Live/Registered |
ARIAD Pharmaceuticals, Inc. 2015-10-23 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.