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.
Benztropine Mesylate
Benztropine Mesylate · BENZTROPINE MESYLATE 1 mg/mL · Injection, Solution · Intramuscular; Intravenous · Fresenius Kabi USA, LLC
NDC 63323-0970-02 · 5 VIAL in 1 BOX / 2 mL in 1 VIAL · ANDA · 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
$275.00
Reported to Texas DSHS · 2026 annual filing · Fresenius Kabi USA
Manufacturer list price as filed — not what pharmacies actually pay after discounts.
Medicaid spend (2024)
$619
12 prescriptions paid by Medicaid nationally · all Medicaid spend →
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
Where it's made
- Fresenius Kabi USA, LLCUnited 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 1 of 6 public criteria. Why that matters →
- Part D specialty tier
- Costs ≥ $950/fill · avg $12.33 per prescription
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program
Regulatory
- Application
- ANDA090233
- TE code
- AP
- Approval date
- Jul 28, 2009
- Patents / exclusivity
- None on file
Shortage history
- Planned discontinuation — Benztropine Mesylate, Injection, 1 mg/1 mL (NDC 63323-970-02)Jan 27, 2026
Recalls (this NDC)
- Class II · TerminatedJul 1, 2013Fresenius Kabi USA, LLC — Presence of particulate matter: characterized as thin colorless flakes that are visually and chemically consistent with glass delamination observed in reserve sample vials
Manufacturers of Benztropine Mesylate (Injection, Solution)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Fresenius Kabi USA, LLC | BENZTROPINE MESYLATE 1 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Benztropine Mesylate — NDC 63323-0970-02," retrieved September 3, 2026, https://drugdashboards.com/drug/63323097002.
Free to cite with attribution — see how the data is put together.