The short version
Just 3 companies supply this market — thin enough that a single exit would be felt immediately.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Iron Sucrose
Iron Sucrose · IRON SUCROSE 100 mg/5mL · Injection, Solution · Intravenous · Mylan Institutional LLC
NDC 67457-0638-10 · 10 VIAL, SINGLE-DOSE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-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
$599.10
Reported to Texas DSHS · 2026 annual filing · Mylan Institutional Inc.
Manufacturer list price as filed — not what pharmacies actually pay after discounts.
Medicare Part B (ASP)
Payment limit per 1 MG
$0.227
HCPCS J1756 · Jul 1, 2026 quarter · typically ASP + 6%
Medicaid spend (2025)
$255,186
5,297 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
- ANDA212559
- TE code
- AB
- Approval date
- Aug 8, 2025
- Patents / exclusivity
- 0 patents, 2 exclusivities
| Type | Number / code | Expires |
|---|---|---|
| exclusivity | CGT | Feb 7, 2026 |
| exclusivity | CGT | Feb 7, 2026 |
Shortage history
- Planned discontinuation — Iron Sucrose, Injection, 50 mg/2.5 mL (NDC 67457-957-99)May 21, 2026
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of Iron Sucrose (Injection, Solution)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Fresenius Medical Care Holdings, Inc. | IRON SUCROSE 20 mg/mL | Jul 15, 2026 | Sep 3, 2026 |
| Mylan Institutional LLC | IRON SUCROSE 100 mg/5mL | Jul 15, 2026 | Sep 2, 2026 |
| Mylan Institutional LLC | IRON SUCROSE 200 mg/10mL | Jul 15, 2026 | Sep 2, 2026 |
| Mylan Institutional LLC | IRON SUCROSE 50 mg/2.5mL | Jul 15, 2026 | Sep 2, 2026 |
| American Regent, Inc. | IRON SUCROSE 20 mg/mL | Jul 15, 2026 | Aug 31, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Iron Sucrose — NDC 67457-0638-10," retrieved September 3, 2026, https://drugdashboards.com/drug/67457063810.
Free to cite with attribution — see how the data is put together.