BRUKINSA
- Product NDC
- 72579-122
- 11-digit product format
- 725790122
- Labeler code
- 72579
- Product ID
- 72579-122_cb0c9753-cca4-421e-9512-1b710a56b342
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- zanubrutinib
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- BeOne Medicines USA, Inc.
- Application
- NDA218785
- Marketing category
- NDA
- Marketing start
- 2025-08-18
- Substance
- ZANUBRUTINIB
- Active strength
- 160 mg/1
- Pharmacologic classes
- Bruton's Tyrosine Kinase Inhibitors [MoA], Kinase Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ce6511ac-9936-4e22-a18a-3d3144ad16b3 | Product name | 1 | 20200428 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 72579-122-01 | BRUKINSA | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | 22 | |
| 72579-122-01 | BRUKINSA | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 22 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 72579-122-01 | EA - Each | 72579-122 | 04c05ca9-d61f-41f3-838e-79f5afa8d685 | 1 | 2025-09-12 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2719223 | Brukinsa 160 MG Oral Tablet | PSN | 3e08fe23-d70e-424c-bc51-1222e320f902 | 22 |
| 2262446 | Brukinsa 80 MG Oral Capsule | PSN | 3e08fe23-d70e-424c-bc51-1222e320f902 | 22 |
| 2719220 | zanubrutinib 160 MG Oral Tablet | PSN | 3e08fe23-d70e-424c-bc51-1222e320f902 | 22 |
| 2262440 | zanubrutinib 80 MG Oral Capsule | PSN | 3e08fe23-d70e-424c-bc51-1222e320f902 | 22 |
| 2719223 | zanubrutinib 160 MG Oral Tablet [Brukinsa] | SBD | 3e08fe23-d70e-424c-bc51-1222e320f902 | 22 |
| 2262446 | zanubrutinib 80 MG Oral Capsule [Brukinsa] | SBD | 3e08fe23-d70e-424c-bc51-1222e320f902 | 22 |
| 2719220 | zanubrutinib 160 MG Oral Tablet | SCD | 3e08fe23-d70e-424c-bc51-1222e320f902 | 22 |
| 2262440 | zanubrutinib 80 MG Oral Capsule | SCD | 3e08fe23-d70e-424c-bc51-1222e320f902 | 22 |
| 2719223 | Brukinsa 160 MG Oral Tablet | SY | 3e08fe23-d70e-424c-bc51-1222e320f902 | 22 |
| 2262446 | Brukinsa 80 MG Oral Capsule | SY | 3e08fe23-d70e-424c-bc51-1222e320f902 | 22 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 72579-122-01 | 72579012201 | 1 BOTTLE in 1 CARTON (72579-122-01) / 60 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2025-08-18 | No | No | Historical |