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.
Hycamtin
topotecan hydrochloride · TOPOTECAN HYDROCHLORIDE 4 mg/4mL · Injection, Powder, Lyophilized, For Solution · Intravenous · Novartis Pharmaceuticals Corporation
NDC 00078-0674-61 · 1 VIAL, SINGLE-DOSE in 1 CARTON / 4 mL in 1 VIAL, SINGLE-DOSE · 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
$114.59
Reported to Texas DSHS · 2024 annual filing · Sandoz Inc.
Manufacturer list price as filed — not what pharmacies actually pay after discounts.
Medicaid spend (2022)
$0
54 prescriptions paid by Medicaid nationally · all Medicaid spend →
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
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
- NDA020671
- TE code
- AP
- Approval date
- May 28, 1996
- 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, "Hycamtin — NDC 00078-0674-61," retrieved September 3, 2026, https://drugdashboards.com/drug/00078067461.
Free to cite with attribution — see how the data is put together.