DrugDashboards

Nicardipine Hydrochloride

nicardipine hydrochloride · NICARDIPINE .2 mg/mL · Injection · Intravenous · Cipla USA Inc.

NDC 69097-0008-22 · 10 BAG in 1 CARTON / 200 mL in 1 BAG · ANDA · View full market →

The short version

11 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.

Estimated fill cost

WAC per package, as filed
$800.00
Reported to Texas DSHS · 2025 annual filing · Cipla USA Inc.

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

Medicare Part B (ASP)

Payment limit per 0.1 MG
$0.070
HCPCS J2404 · Jul 1, 2026 quarter · typically ASP + 6%

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
ANDA215592
TE code
AP
Approval date
Sep 24, 2024
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 nicardipine hydrochloride (Injection)

LabelerStrengthFirst seenLast seen
Armas Pharmaceuticals Inc.NICARDIPINE HYDROCHLORIDE 25 mg/10mLJul 15, 2026Sep 2, 2026
Caplin Steriles LimitedNICARDIPINE HYDROCHLORIDE .1 mg/mLJul 15, 2026Sep 2, 2026
Caplin Steriles LimitedNICARDIPINE HYDROCHLORIDE .2 mg/mLJul 15, 2026Sep 2, 2026
Chengdu Shuode Pharmaceutical Co., LtdNICARDIPINE HYDROCHLORIDE 25 mg/10mLJul 15, 2026Sep 2, 2026
Cipla USA Inc.NICARDIPINE .2 mg/mLJul 15, 2026Sep 2, 2026
Cipla USA Inc.NICARDIPINE HYDROCHLORIDE .1 mg/mLJul 15, 2026Sep 2, 2026
Fresenius Kabi USA, LLCNICARDIPINE HYDROCHLORIDE 25 mg/10mLJul 15, 2026Sep 2, 2026
HF Acquisition Co LLC, DBA HealthFirstNICARDIPINE HYDROCHLORIDE 25 mg/10mLJul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.NICARDIPINE HYDROCHLORIDE 25 mg/10mLJul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.NICARDIPINE HYDROCHLORIDE .1 mg/mLJul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.NICARDIPINE HYDROCHLORIDE .2 mg/mLJul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.NICARDIPINE HYDROCHLORIDE 2.5 mg/mLJul 15, 2026Sep 2, 2026
Lifestar Pharma LLCNICARDIPINE HYDROCHLORIDE 2.5 mg/mLJul 15, 2026Sep 2, 2026
Micro Labs LimitedNICARDIPINE HYDROCHLORIDE 2.5 mg/mLJul 15, 2026Sep 2, 2026
Somerset Therapeutics, LLCNICARDIPINE HYDROCHLORIDE .2 mg/mLJul 15, 2026Sep 2, 2026
Somerset Therapeutics, LLCNICARDIPINE HYDROCHLORIDE .1 mg/mLJul 15, 2026Sep 2, 2026
West-Ward Pharmaceuticals CorpNICARDIPINE HYDROCHLORIDE 2.5 mg/mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Nicardipine Hydrochloride — NDC 69097-0008-22," retrieved September 3, 2026, https://drugdashboards.com/drug/69097000822.

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