Bosutinib
- Product NDC
- 62332-311
- 11-digit product format
- 623320311
- Labeler code
- 62332
- Product ID
- 62332-311_45618427-a81b-436a-9326-8de755cb1eb9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bosutinib
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Inc.
- Application
- ANDA209543
- Marketing category
- ANDA
- Marketing start
- 2026-05-19
- Substance
- BOSUTINIB
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Bosutinib
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BOSUTINIB | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5018V4AEZ0 |
| Rxcui | 1307624, 1307633 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62332-311-35 | Bosutinib | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | | 20 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 62332-311-35 | 62332031135 | 120 TABLET, FILM COATED in 1 BOTTLE (62332-311-35) | 2026-05-19 | No | No | Current |