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.
Saphnelo
Anifrolumab-fnia · ANIFROLUMAB 120 mg/.8mL · Injection, Solution · Subcutaneous · AstraZeneca Pharmaceuticals LP
NDC 00310-3080-01 · 1 SYRINGE, GLASS in 1 CARTON / .8 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.
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
Where it's made
- Samsung Biologics Co., Ltd.Korea, Southanalysis · api 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 3 of 6 public criteria. Why that matters →
- Part D specialty tier
- Costs ≥ $950/fill · avg $5,094.70 per prescription
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program
Regulatory
- Application
- BLA761451
- 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 Anifrolumab-fnia (Injection, Solution)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| AstraZeneca Pharmaceuticals LP | ANIFROLUMAB 120 mg/.8mL | Jul 15, 2026 | Sep 2, 2026 |
| AstraZeneca Pharmaceuticals LP | ANIFROLUMAB 300 mg/2mL | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Saphnelo — NDC 00310-3080-01," retrieved September 3, 2026, https://drugdashboards.com/drug/00310308001.
Free to cite with attribution — see how the data is put together.