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.
Tepadina
thiotepa · THIOTEPA 200 mg/1 · Injection, Powder, Lyophilized, For Solution · Intracavitary; Intravenous; Intravesical · Amneal Pharmaceuticals LLC
NDC 70121-2749-01 · 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 BOX · NDA · 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.
Estimated fill cost
WAC per package, as filed
$1,620.00
Reported to Texas DSHS · 2026 annual filing · Amneal Pharmaceuticals LLC
Manufacturer list price as filed — not what pharmacies actually pay after discounts.
Medicare Part B (ASP)
Payment limit per 1 MG
$4.931
HCPCS J9342 · Jul 1, 2026 quarter · typically ASP + 6%
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
Where it's made
- Adienne S.r.l.Italyanalysis · manufacture
- Cit SrlItalypack
- Eurofins Biolab SrlItalyanalysis
- Indena SpAItalyapi manufacture
- Indena SpAItalyanalysis · api manufacture
- analysis
- NerPharMa S.r.lItalyanalysis
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
- NDA208264
- TE code
- AP
- Approval date
- Jan 26, 2017
- Patents / exclusivity
- 2 patents, 0 exclusivities
| Type | Number / code | Expires |
|---|---|---|
| patent | 9931458 | May 31, 2037 |
| patent | 9931458 | May 31, 2037 |
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, "Tepadina — NDC 70121-2749-01," retrieved September 3, 2026, https://drugdashboards.com/drug/70121274901.
Free to cite with attribution — see how the data is put together.