DrugDashboards

Hydralazine Hydrochloride

Hydralazine Hydrochloride · HYDRALAZINE HYDROCHLORIDE 20 mg/mL · Injection · Intramuscular; Intravenous · Baxter Healthcare Corporation

NDC 43066-0041-25 · 25 VIAL, SINGLE-DOSE in 1 CARTON / 1 mL in 1 VIAL, SINGLE-DOSE · ANDA · View full market →

The short version

12 companies supply this market — deep enough that no single failure threatens the supply. One of its named manufacturing plants, Immacule Lifesciences Private Limited, failed FDA inspectionwithin the last two years — the agency’s most serious outcome.

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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
$11.00
Reported to Texas DSHS · 2026 annual filing · Baxter Healthcare Corporation

Manufacturer list price as filed — not what pharmacies actually pay after discounts.

Medicare Part B (ASP)

Payment limit per 20 MG
$3.395
HCPCS J0360 · Jul 1, 2026 quarter · typically ASP + 6%

Medicaid spend (2025)

$403
68 prescriptions paid by Medicaid nationally · all Medicaid spend →

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
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
ANDA219797
TE code
AP
Approval date
Jul 17, 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 Hydralazine Hydrochloride (Injection)

LabelerStrengthFirst seenLast seen
Cardinal Health 107, LLCHYDRALAZINE HYDROCHLORIDE 20 mg/mLJul 15, 2026Sep 3, 2026
Fresenius Kabi USA, LLCHYDRALAZINE HYDROCHLORIDE 20 mg/mLJul 15, 2026Sep 3, 2026
Medical Purchasing Solutions, LLCHYDRALAZINE HYDROCHLORIDE 20 mg/mLJul 15, 2026Sep 3, 2026
Baxter Healthcare CorporationHYDRALAZINE HYDROCHLORIDE 20 mg/mLJul 15, 2026Sep 2, 2026
Eugia US LLCHYDRALAZINE HYDROCHLORIDE 20 mg/mLJul 15, 2026Sep 2, 2026
Henry Schein, Inc.HYDRALAZINE HYDROCHLORIDE 20 mg/mLJul 15, 2026Sep 2, 2026
Meitheal Pharmaceuticals Inc.HYDRALAZINE HYDROCHLORIDE 20 mg/mLJul 15, 2026Sep 2, 2026
Navinta LLCHYDRALAZINE HYDROCHLORIDE 20 mg/mLJul 15, 2026Sep 2, 2026
ProPharma DistributionHYDRALAZINE HYDROCHLORIDE 20 mg/mLJul 15, 2026Sep 2, 2026
Remedyrepack Inc.HYDRALAZINE HYDROCHLORIDE 20 mg/mLJul 15, 2026Sep 2, 2026
Zydus Pharmaceuticals USA Inc.HYDRALAZINE HYDROCHLORIDE 20 mg/mLJul 15, 2026Sep 2, 2026
HF Acquisition Co LLC, DBA HealthFirstHYDRALAZINE HYDROCHLORIDE 20 mg/mLJul 15, 2026Aug 31, 2026

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

Cite this page

DrugDashboards, "Hydralazine Hydrochloride — NDC 43066-0041-25," retrieved September 3, 2026, https://drugdashboards.com/drug/43066004125.

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