BOSULIF
- Product NDC
- 63539-117
- 11-digit product format
- 635390117
- Labeler code
- 63539
- Product ID
- 63539-117_6550da0f-5049-4056-b705-ffbcf2ac00cf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bosutinib
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- U.S. Pharmaceuticals
- Application
- NDA203341
- Marketing category
- NDA
- Marketing start
- 2012-09-04
- Substance
- BOSUTINIB MONOHYDRATE
- Active strength
- 100 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
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63539-117-01 | BOSULIF | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | | 6 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| BOSUTINIB MONOHYDRATE | ACTIVE INGREDIENT | 844ZJE6I55 | BOSULIF (BOSUTINIB MONOHYDRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS] | 1 | |
| BOSUTINIB | ACTIVE MOIETY | 5018V4AEZ0 | BOSULIF (BOSUTINIB MONOHYDRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | BOSULIF (BOSUTINIB MONOHYDRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | BOSULIF (BOSUTINIB MONOHYDRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | BOSULIF (BOSUTINIB MONOHYDRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | BOSULIF (BOSUTINIB MONOHYDRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS] | 1 | |
| POLOXAMER 188 | INACTIVE INGREDIENT | LQA7B6G8JG | BOSULIF (BOSUTINIB MONOHYDRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS] | 1 | |
| POLYETHYLENE GLYCOL 3350 | INACTIVE INGREDIENT | G2M7P15E5P | BOSULIF (BOSUTINIB MONOHYDRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS] | 1 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | BOSULIF (BOSUTINIB MONOHYDRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS] | 1 | |
| POVIDONE K25 | INACTIVE INGREDIENT | K0KQV10C35 | BOSULIF (BOSUTINIB MONOHYDRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | BOSULIF (BOSUTINIB MONOHYDRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | BOSULIF (BOSUTINIB MONOHYDRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63539-117 | BOSULIF (BOSUTINIB) TABLET, FILM COATED [U.S. PHARMACEUTICALS] | 4 | Current NDC, Legacy NDC, 1 package rows | 20250328_d5929f91-6496-4c0e-97e8-0bd524e15763.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63539-117-01 | 63539011701 | 120 TABLET, FILM COATED in 1 BOTTLE (63539-117-01) | 2012-09-04 | 0000-00-00 | No | No | Current |