The short version
Only one company currently supplies this market — there is no backup if it stumbles.
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Mircera
Methoxy polyethylene glycol-epoetin beta · METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA 50 ug/.3mL · Injection, Solution · Intravenous · Vifor (International) Inc.
NDC 59353-0401-09 · 1 SYRINGE, GLASS in 1 CARTON / 1 mL in 1 SYRINGE, GLASS · BLA · 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
$144.00
Reported to Texas DSHS · 2026 annual filing · Vifor (International) Inc.
Manufacturer list price as filed — not what pharmacies actually pay after discounts.
Medicare Part B (ASP)
Payment limit per 1 MCG
$1.090
HCPCS J0887 · Jul 1, 2026 quarter · typically ASP + 6%
Medicaid spend (2025)
$4.0M
59,789 prescriptions paid by Medicaid nationally · all Medicaid spend →
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
Where it's made
- analysis
- F. Hoffmann-La Roche AGSwitzerlandanalysis · manufacture
- Roche Diagnostics GmbHGermanyanalysis · manufacture
- Roche Diagnostics GmbHGermanyapi 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 2 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
- BLA125164
- TE code
- —
- Approval date
- —
- 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 Methoxy polyethylene glycol-epoetin beta (Injection, Solution)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Vifor (International) Inc. | METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA 100 ug/.3mL | Jul 15, 2026 | Sep 1, 2026 |
| Vifor (International) Inc. | METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA 120 ug/.3mL | Jul 15, 2026 | Sep 1, 2026 |
| Vifor (International) Inc. | METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA 150 ug/.3mL | Jul 15, 2026 | Sep 1, 2026 |
| Vifor (International) Inc. | METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA 200 ug/.3mL | Jul 15, 2026 | Sep 1, 2026 |
| Vifor (International) Inc. | METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA 250 ug/.3mL | Jul 15, 2026 | Sep 1, 2026 |
| Vifor (International) Inc. | METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA 30 ug/.3mL | Jul 15, 2026 | Sep 1, 2026 |
| Vifor (International) Inc. | METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA 360 ug/.6mL | Jul 15, 2026 | Sep 1, 2026 |
| Vifor (International) Inc. | METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA 50 ug/.3mL | Jul 15, 2026 | Sep 1, 2026 |
| Vifor (International) Inc. | METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA 75 ug/.3mL | Jul 15, 2026 | Sep 1, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Mircera — NDC 59353-0401-09," retrieved September 3, 2026, https://drugdashboards.com/drug/59353040109.
Free to cite with attribution — see how the data is put together.