DrugDashboards

Acetylcysteine

Acetylcysteine · ACETYLCYSTEINE 200 mg/mL · Injection, Solution · Intravenous · Hikma Pharmaceuticals USA Inc.

NDC 00143-9433-04 · 4 VIAL in 1 CARTON / 30 mL in 1 VIAL · ANDA · View full market →

The short version

9 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.

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 $92.69 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
ANDA217182
TE code
AP
Approval date
Apr 19, 2023
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 Acetylcysteine (Injection, Solution)

LabelerStrengthFirst seenLast seen
Sagent PharmaceuticalsACETYLCYSTEINE 200 mg/mLJul 15, 2026Sep 3, 2026
Cumberland Pharmaceuticals Inc.ACETYLCYSTEINE 200 mg/mLJul 15, 2026Sep 2, 2026
Eugia US LLCACETYLCYSTEINE 6 g/30mLJul 15, 2026Sep 2, 2026
Glenmark Pharmaceuticals Inc., USAACETYLCYSTEINE 200 mg/mLJul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.ACETYLCYSTEINE 200 mg/mLJul 15, 2026Sep 2, 2026
Onesource Specialty Pharma LimitedACETYLCYSTEINE 200 mg/mLJul 15, 2026Sep 2, 2026
Somerset Therapeutics, LLCACETYLCYSTEINE 200 mg/mLJul 15, 2026Sep 2, 2026
Xellia Pharmaceuticals USA LLCACETYLCYSTEINE 200 mg/mLJul 15, 2026Sep 2, 2026
Fresenius Kabi USA, LLCACETYLCYSTEINE 200 mg/mLJul 15, 2026Aug 31, 2026

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

Cite this page

DrugDashboards, "Acetylcysteine — NDC 00143-9433-04," retrieved September 3, 2026, https://drugdashboards.com/drug/00143943304.

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