The short version
Only one company currently supplies this market — there is no backup if it stumbles.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Topotecan
Topotecan · TOPOTECAN 1 mg/mL · Injection · Intravenous · Accord Healthcare Inc.
NDC 16729-0243-31 · 1 VIAL, MULTI-DOSE in 1 CARTON / 4 mL in 1 VIAL, MULTI-DOSE · 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 (2024)
$1,438
68 prescriptions paid by Medicaid nationally · all Medicaid spend →
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
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program
Regulatory
- Application
- ANDA204406
- TE code
- AP
- Approval date
- Jul 6, 2017
- 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 (Injection)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Accord Healthcare Inc. | TOPOTECAN 1 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Topotecan — NDC 16729-0243-31," retrieved September 3, 2026, https://drugdashboards.com/drug/16729024331.
Free to cite with attribution — see how the data is put together.