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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- BRUKINSA
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ZANUBRUTINIB | 160 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | AG9MHG098Z |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| 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 RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| 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 | Current |