The short version
5 companies supply this market — a reasonable cushion if one runs into trouble.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Bosutinib
Bosutinib · BOSUTINIB 500 mg/1 · Tablet, Film Coated · Oral · Alembic Pharmaceuticals Limited
NDC 46708-0312-30 · 30 TABLET, FILM COATED in 1 BOTTLE · ANDA · View full market →
Medicare Part D
No Medicare Part D plan in CMS's quarterly files lists this product. That usually means it is discontinued, a repackager's listing, or a product no plan has added to its formulary.
How Part D pricing works →NADAC price per unit
No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
Where it's made
- manufacture
Establishments this product's FDA label declares, located via FDA registration data. How we built this →
Is this a "specialty" drug?
There's no legal definition — it meets 1 of 6 public criteria. Why that matters →
- Part D specialty tier
- Costs ≥ $950/fill · avg $15,141.36 per prescription
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program
Regulatory
- Application
- ANDA209543
- TE code
- AB
- Approval date
- May 23, 2025
- Patents / exclusivity
- 0 patents, 2 exclusivities
| Type | Number / code | Expires |
|---|---|---|
| exclusivity | PC | Dec 8, 2026 |
| exclusivity | PC | Dec 8, 2026 |
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of Bosutinib (Tablet, Film Coated)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Alembic Pharmaceuticals Inc. | BOSUTINIB 100 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Alembic Pharmaceuticals Inc. | BOSUTINIB 500 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Alembic Pharmaceuticals Limited | BOSUTINIB 500 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Alembic Pharmaceuticals Limited | BOSUTINIB 100 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Dr. Reddy's Laboratories Inc. | BOSUTINIB 400 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Pfizer Laboratories Div Pfizer Inc | BOSUTINIB MONOHYDRATE 100 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Pfizer Laboratories Div Pfizer Inc | BOSUTINIB MONOHYDRATE 400 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Pfizer Laboratories Div Pfizer Inc | BOSUTINIB MONOHYDRATE 500 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| U.S. Pharmaceuticals | BOSUTINIB MONOHYDRATE 400 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Bosutinib — NDC 46708-0312-30," retrieved September 3, 2026, https://drugdashboards.com/drug/46708031230.
Free to cite with attribution — see how the data is put together.