DrugDashboards

Benztropine Mesylate

Benztropine Mesylate · BENZTROPINE MESYLATE 1 mg/mL · Injection · Intramuscular; Intravenous · Navinta LLC

NDC 68475-0512-02 · 5 VIAL in 1 CARTON / 2 mL in 1 VIAL · ANDA · View full market →

The short version

Just 3 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.

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 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
ANDA091525
TE code
AP
Approval date
Feb 5, 2013
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 Benztropine Mesylate (Injection)

LabelerStrengthFirst seenLast seen
Hikma Pharmaceuticals USA Inc.BENZTROPINE MESYLATE 1 mg/mLJul 15, 2026Sep 3, 2026
Navinta LLCBENZTROPINE MESYLATE 1 mg/mLJul 15, 2026Sep 2, 2026
Zydus Pharmaceuticals USA Inc.BENZTROPINE MESYLATE 1 mg/mLJul 15, 2026Sep 2, 2026

Roster from daily NDC Directory diffs — first/last seen dates start July 2026.

Cite this page

DrugDashboards, "Benztropine Mesylate — NDC 68475-0512-02," retrieved September 3, 2026, https://drugdashboards.com/drug/68475051202.

Free to cite with attribution — see how the data is put together.