DrugDashboards

Atropine Sulfate

Atropine Sulfate Injection · ATROPINE SULFATE .1 mg/mL · Injection, Solution · Intravenous · ProPharma Distribution

NDC 84549-0400-91 · 10 mL in 1 SYRINGE, PLASTIC · ANDA · View full market →

The short version

Just 2 companies supply this market — thin enough that a single exit would be felt immediately. It is in shortage right now.

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.

Where it's made

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 $47.18 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
ANDA214970
TE code
AP
Approval date
Nov 4, 2022
Patents / exclusivity
None on file

Shortage history

  • In shortage now Atropine Sulfate, Injection, 1 mg/10 mL (0.1 mg/mL) Syringes (NDC 64253-400-91)Jan 1, 2012
    month 177 — 9× the typical 20-month injectable shortage · model puts 21% odds it resolves within 6 months

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Atropine Sulfate Injection (Injection, Solution)

LabelerStrengthFirst seenLast seen
Medefil, Inc.ATROPINE SULFATE .1 mg/mLJul 15, 2026Sep 2, 2026
ProPharma DistributionATROPINE SULFATE .1 mg/mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Atropine Sulfate — NDC 84549-0400-91," retrieved September 3, 2026, https://drugdashboards.com/drug/84549040091.

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