The short version
Just 2 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.
Nypozi
filgrastim-txid · FILGRASTIM 300 ug/300ug · Injection · Intravenous; Subcutaneous · Cipla USA Inc.
NDC 69097-0430-67 · 1 SYRINGE, GLASS in 1 CARTON / 300 ug 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.
Medicare Part B (ASP)
Payment limit per 1 MCG
$1.034
HCPCS Q5148 · Jul 1, 2026 quarter · typically ASP + 6%
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
Where it's made
- Tanvex BioPharma USA, IncUnited Statesmanufacture
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
- BLA761126
- 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 filgrastim-txid (Injection)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Cipla USA Inc. | FILGRASTIM 300 ug/300ug | Jul 15, 2026 | Sep 2, 2026 |
| Cipla USA Inc. | FILGRASTIM 480 ug/480ug | Jul 15, 2026 | Sep 2, 2026 |
| Tanvex BioPharma USA, Inc. | FILGRASTIM 300 ug/300ug | Jul 15, 2026 | Sep 2, 2026 |
| Tanvex BioPharma USA, Inc. | FILGRASTIM 480 ug/480ug | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Nypozi — NDC 69097-0430-67," retrieved September 3, 2026, https://drugdashboards.com/drug/69097043067.
Free to cite with attribution — see how the data is put together.