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.
Cytalux
Pafolacianine injection · PAFOLACIANINE SODIUM 3.2 mg/1.6mL · Injection · Intravenous · On Target Laboratories, Inc.
NDC 81052-0138-10 · 10 CARTON in 1 CARTON / 1 VIAL, SINGLE-DOSE in 1 CARTON / 1.6 mL in 1 VIAL, SINGLE-DOSE · NDA · 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.
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
- NDA214907
- TE code
- —
- Approval date
- Nov 29, 2021
- Patents / exclusivity
- 6 patents, 2 exclusivities
| Type | Number / code | Expires |
|---|---|---|
| exclusivity | ODE-390 | Nov 29, 2028 |
| exclusivity | NCE | Nov 29, 2026 |
| patent | 9061057 | Nov 29, 2035 |
| patent | 9254341 | Oct 4, 2033 |
| patent | 9333270 | Aug 26, 2033 |
| patent | 9341629 | Aug 26, 2033 |
| patent | 9789208 | Aug 26, 2033 |
| patent | 10881747 | Aug 26, 2033 |
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of Pafolacianine injection (Injection)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| On Target Laboratories, Inc. | PAFOLACIANINE SODIUM 3.2 mg/1.6mL | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Cytalux — NDC 81052-0138-10," retrieved September 3, 2026, https://drugdashboards.com/drug/81052013810.
Free to cite with attribution — see how the data is put together.