DrugDashboards

Acetaminophen

Acetaminophen · ACETAMINOPHEN 10 mg/mL · Injection, Solution · Intravenous · Caplin Steriles Limited

NDC 65145-0157-10 · 10 POUCH in 1 CASE / 1 BAG in 1 POUCH / 100 mL in 1 BAG · ANDA · View full market →

The short version

14 companies supply this market — deep enough that no single failure threatens the supply.

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 2 of 6 public criteria. Why that matters →

  • Part D specialty tier
  • Costs ≥ $950/fill · avg $171.51 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program · Opioid Analgesic REMS Shared System REMS

Regulatory

Application
ANDA219096
TE code
AP1
Approval date
Dec 5, 2025
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 Acetaminophen (Injection, Solution)

LabelerStrengthFirst seenLast seen
Baxter Healthcare CorporationACETAMINOPHEN 10 mg/mLJul 15, 2026Sep 3, 2026
Hikma Pharmaceuticals USA Inc.ACETAMINOPHEN 10 mg/mLJul 15, 2026Sep 3, 2026
Sandoz IncACETAMINOPHEN 10 mg/mLJul 15, 2026Sep 3, 2026
Camber Pharmaceuticals, Inc.ACETAMINOPHEN 10 mg/mLJul 15, 2026Sep 2, 2026
Caplin Steriles LimitedACETAMINOPHEN 10 mg/mLJul 15, 2026Sep 2, 2026
Civica, Inc.ACETAMINOPHEN 10 mg/mLJul 15, 2026Sep 2, 2026
Eugia US LLCACETAMINOPHEN 10 mg/mLJul 15, 2026Sep 2, 2026
HF Acquisition Co LLC, DBA HealthFirstACETAMINOPHEN 10 mg/mLJul 15, 2026Sep 2, 2026
Mylan Institutional LLCACETAMINOPHEN 1000 mg/100mLJul 15, 2026Sep 2, 2026
Remedyrepack Inc.ACETAMINOPHEN 10 mg/mLJul 15, 2026Sep 2, 2026
Sagent PharmaceuticalsACETAMINOPHEN 10 mg/mLJul 15, 2026Sep 2, 2026
Solupharm Pharmazeutische Erzeugnisse GmbHACETAMINOPHEN 10 mg/mLJul 15, 2026Sep 2, 2026
WG Critical Care, LLCACETAMINOPHEN 10 mg/mLJul 15, 2026Sep 2, 2026
Gland Pharma LimitedACETAMINOPHEN 10 mg/mLJul 15, 2026Aug 31, 2026

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

Cite this page

DrugDashboards, "Acetaminophen — NDC 65145-0157-10," retrieved September 3, 2026, https://drugdashboards.com/drug/65145015710.

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