BOSULIF
- Product NDC
- 0069-0504
- 11-digit product format
- 000690504
- Labeler code
- 0069
- Product ID
- 0069-0504_ca8600d9-46e6-402d-89f9-bc6a156bf751
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bosutinib
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Pfizer Laboratories Div Pfizer Inc
- Application
- NDA217729
- Marketing category
- NDA
- Marketing start
- 2024-01-02
- Substance
- BOSUTINIB MONOHYDRATE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Bcr-Abl 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 |
|---|
| 844ZJE6I55 | BOSUTINIB MONOHYDRATE | 918639-08-4 | BOSUTINIB MONOHYDRATE |
| 5018V4AEZ0 | BOSUTINIB | 380843-75-4 | Bosutinib |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0069-0504-30 | 00069050430 | 30 CAPSULE in 1 BOTTLE (0069-0504-30) | 30 capsule | 2024-01-02 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| BOSULIF | Pfizer Laboratories Div Pfizer Inc | Pfizer Manufacturing Deutschland GmbH | Pfizer Ireland Pharmaceuticals Unlimited Company | 2026-03-10 | HUMAN PRESCRIPTION DRUG LABEL | 32 |