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.
Advate
Antihemophilic Factor (Recombinant) · Kit · Takeda Pharmaceuticals America, Inc.
NDC 00944-3053-02 · 1 BLISTER PACK in 1 CARTON / 1 CONTAINER in 1 BLISTER PACK / 1 KIT in 1 CONTAINER * 5 mL in 1 VIAL, GLASS * 2 mL in 1 VIAL, 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
$1.96
Reported to Texas DSHS · 2026 annual filing · Baxalta
Manufacturer list price as filed — not what pharmacies actually pay after discounts.
Medicare Part B (ASP)
Payment limit per 1 IU
$1.580
HCPCS J7192 · Jul 1, 2026 quarter · typically ASP + 6%
Medicaid spend (2025)
$2.0M
257 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
- BLA125063
- 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 Antihemophilic Factor (Recombinant) (Kit)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Bayer HealthCare LLC | Jul 15, 2026 | Sep 3, 2026 | |
| Octapharma USA Inc | Jul 15, 2026 | Sep 3, 2026 | |
| Takeda Pharmaceuticals America, Inc. | Jul 15, 2026 | Sep 3, 2026 | |
| Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC | Jul 15, 2026 | Sep 3, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Advate — NDC 00944-3053-02," retrieved September 3, 2026, https://drugdashboards.com/drug/00944305302.
Free to cite with attribution — see how the data is put together.