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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| AG9MHG098Z | ZANUBRUTINIB | 1691249-45-2 | ZANUBRUTINIB |
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 |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| BRUKINSA | BeOne Medicines USA, Inc. | AndersonBrecon Inc. | Changzhou SynTheAll Pharmaceutical Co., Ltd | Catalent CTS, LLC | BeOne Pharmaceutical (Suzhou) Co.,Ltd | Catalent Pharma Solutions, LLC | Allpack Group AG | Siegfried Evionnaz SA | Sharp Packaging Services, LLC | 2026-02-02 | HUMAN PRESCRIPTION DRUG LABEL | 22 |