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.
Sincalide
Sincalide · SINCALIDE 5 ug/5mL · Injection, Powder, Lyophilized, For Solution · Intravenous · MAIA Pharmaceuticals, Inc.
NDC 70511-0131-84 · 10 VIAL in 1 PACKAGE / 5 mL in 1 VIAL · 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.
Where it's made
- Gland Pharma LimitedIndiamanufacture
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 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
- NDA210850
- TE code
- AP
- Approval date
- Nov 22, 2022
- Patents / exclusivity
- 3 patents, 0 exclusivities
| Type | Number / code | Expires |
|---|---|---|
| patent | 11737983 | Apr 20, 2038 |
| patent | 11318100 | Apr 20, 2038 |
| patent | 11110063 | Apr 20, 2038 |
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of Sincalide (Injection, Powder, Lyophilized, For Solution)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Bracco Diagnostics Inc. | SINCALIDE 5 ug/5mL | Jul 15, 2026 | Sep 2, 2026 |
| Fosun Pharma Usa Inc | SINCALIDE 5 ug/5mL | Jul 15, 2026 | Sep 2, 2026 |
| Fresenius Kabi USA, LLC | SINCALIDE 5 ug/5mL | Jul 15, 2026 | Sep 2, 2026 |
| MAIA Pharmaceuticals, Inc. | SINCALIDE 5 ug/5mL | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Sincalide — NDC 70511-0131-84," retrieved September 3, 2026, https://drugdashboards.com/drug/70511013184.
Free to cite with attribution — see how the data is put together.