The short version
7 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.
Thiotepa
Thiotepa · THIOTEPA 15 mg/1 · Injection, Powder, Lyophilized, For Solution · Intracavitary; Intravenous; Intravesical · Gland Pharma Limited
NDC 68083-0446-01 · 1 VIAL in 1 CARTON / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL · 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
- Gland Pharma LimitedIndiaanalysis · label · manufacture · pack
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
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program
Regulatory
- Application
- ANDA214222
- TE code
- AP
- Approval date
- Mar 8, 2021
- Patents / exclusivity
- None on file
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of Thiotepa (Injection, Powder, Lyophilized, For Solution)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Hikma Pharmaceuticals USA Inc. | THIOTEPA 15 mg/1.5mL | Jul 15, 2026 | Sep 3, 2026 |
| Amneal Pharmaceuticals LLC | THIOTEPA 400 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Amneal Pharmaceuticals LLC | THIOTEPA 200 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Dr.Reddy's Laboratories Inc., | THIOTEPA 100 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Dr.Reddy's Laboratories Inc., | THIOTEPA 15 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Fresenius Kabi USA, LLC | THIOTEPA 100 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Gland Pharma Limited | THIOTEPA 15 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Gland Pharma Limited | THIOTEPA 100 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Hikma Pharmaceuticals USA Inc. | THIOTEPA 100 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Novadoz Pharmaceuticals LLC | THIOTEPA 15 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Novadoz Pharmaceuticals LLC | THIOTEPA 100 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Sagent Pharmaceuticals | THIOTEPA 15 mg/1.5mL | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Thiotepa — NDC 68083-0446-01," retrieved September 3, 2026, https://drugdashboards.com/drug/68083044601.
Free to cite with attribution — see how the data is put together.