The short version
4 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.
topotecan hydrochloride
topotecan hydrochloride · TOPOTECAN HYDROCHLORIDE 4 mg/4mL · Injection, Powder, Lyophilized, For Solution · Intravenous · Accord Healthcare, Inc.
NDC 16729-0151-31 · 1 VIAL in 1 PACKAGE / 4 mL 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.
Estimated fill cost
WAC per package, as filed
$140.00
Reported to Texas DSHS · 2026 annual filing · Accord Healthcare, Inc.
Manufacturer list price as filed — not what pharmacies actually pay after discounts.
Medicare Part B (ASP)
Payment limit per 0.1 MG
$2.759
HCPCS J9351 · Jul 1, 2026 quarter · typically ASP + 6%
Medicaid spend (2025)
$23,501
177 prescriptions paid by Medicaid nationally · all Medicaid spend →
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
Where it's made
- analysis · 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
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program
Regulatory
- Application
- ANDA202351
- TE code
- AP
- Approval date
- Jun 26, 2013
- 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 topotecan hydrochloride (Injection, Powder, Lyophilized, For Solution)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Accord Healthcare, Inc. | TOPOTECAN HYDROCHLORIDE 4 mg/4mL | Jul 15, 2026 | Sep 2, 2026 |
| Actavis Pharma, Inc. | TOPOTECAN HYDROCHLORIDE 4 mg/4mL | Jul 15, 2026 | Sep 2, 2026 |
| Fresenius Kabi USA, LLC | TOPOTECAN HYDROCHLORIDE 4 mg/4mL | Jul 15, 2026 | Sep 2, 2026 |
| Novartis Pharmaceuticals Corporation | TOPOTECAN HYDROCHLORIDE 4 mg/4mL | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "topotecan hydrochloride — NDC 16729-0151-31," retrieved September 3, 2026, https://drugdashboards.com/drug/16729015131.
Free to cite with attribution — see how the data is put together.