DrugDashboards

Labetalol Hydrochloride

Labetalol Hydrochloride · LABETALOL HYDROCHLORIDE 5 mg/mL · Injection · Intravenous · Onesource Specialty Pharma Limited

NDC 83270-0178-01 · 1 VIAL, MULTI-DOSE in 1 CARTON / 20 mL in 1 VIAL, MULTI-DOSE · ANDA · View full market →

The short version

5 companies supply this market — a reasonable cushion if one runs into trouble. Historically, drugs in this position went on to a new shortage within 90 days about 0.5% of the time — roughly 3× the typical drug (0.1%).

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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.

Supply fragility

Not scored — fragility is computed for NADAC-priced NDCs.

90-day shortage risk (model v2)

0.5%chance of a new FDA shortage posting for labetalol hydrochloride (injectable) in the next 90 days

sterile injectable · price up 20% YoY · sole-source market

For scale: the typical drug’s chance is about 0.1% — this one is 3× that.

Backtested statistical model over the whole market, not this package alone. Model details →

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
ANDA079134
TE code
—
Approval date
Feb 3, 2010
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 Labetalol Hydrochloride (Injection)

LabelerStrengthFirst seenLast seen
Hikma Pharmaceuticals USA Inc.LABETALOL HYDROCHLORIDE 5 mg/mLJul 15, 2026Sep 3, 2026
Onesource Specialty Pharma LimitedLABETALOL HYDROCHLORIDE 5 mg/mLJul 15, 2026Sep 3, 2026
Civica, Inc.LABETALOL HYDROCHLORIDE 5 mg/mLJul 15, 2026Sep 2, 2026
Mullan Pharmaceutical Inc.LABETALOL HYDROCHLORIDE 100 mg/20mLJul 15, 2026Sep 2, 2026
Mullan Pharmaceutical Inc.LABETALOL HYDROCHLORIDE 200 mg/40mLJul 15, 2026Sep 2, 2026
Fosun Pharma USA Inc.LABETALOL HYDROCHLORIDE 5 mg/mLJul 15, 2026Aug 31, 2026
Hikma Pharmaceuticals USA Inc.LABETALOL HYDROCHLORIDE 1 mg/mLJul 15, 2026Aug 31, 2026

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

Cite this page

DrugDashboards, "Labetalol Hydrochloride — NDC 83270-0178-01," retrieved September 3, 2026, https://drugdashboards.com/drug/83270017801.

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