DrugDashboards

Labetalol Hydrochloride

labetalol hydrochloride · LABETALOL HYDROCHLORIDE 5 mg/mL · Injection, Solution · Intravenous · Amneal Pharmaceuticals LLC

NDC 70121-2428-03 · 24 CARTON in 1 CARTON / 1 SYRINGE, GLASS in 1 CARTON / 4 mL in 1 SYRINGE, GLASS · ANDA · View full market →

The short version

9 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%).

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
$217.98
Reported to Texas DSHS · 2026 annual filing · Amneal Pharmaceuticals LLC

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

Medicare Part B (ASP)

Payment limit per 5 MG
$0.218
HCPCS J1920 · Jul 1, 2026 quarter · typically ASP + 6%

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 →

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
ANDA218870
TE code
AP
Approval date
Oct 2, 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 labetalol hydrochloride (Injection, Solution)

LabelerStrengthFirst seenLast seen
Caplin Steriles LimitedLABETALOL HYDROCHLORIDE 5 mg/mLJul 15, 2026Sep 3, 2026
Amneal Pharmaceuticals LLCLABETALOL HYDROCHLORIDE 5 mg/mLJul 15, 2026Sep 2, 2026
Cardinal Health 107, LLCLABETALOL HYDROCHLORIDE 5 mg/mLJul 15, 2026Sep 2, 2026
Gland Pharma LimitedLABETALOL HYDROCHLORIDE 5 mg/mLJul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.LABETALOL HYDROCHLORIDE 5 mg/mLJul 15, 2026Sep 2, 2026
NorthStar Rx LLCLABETALOL HYDROCHLORIDE 5 mg/mLJul 15, 2026Sep 2, 2026
Sagent PharmaceuticalsLABETALOL HYDROCHLORIDE 5 mg/mLJul 15, 2026Sep 2, 2026
Hospira, Inc.LABETALOL HYDROCHLORIDE 5 mg/mLJul 15, 2026Aug 31, 2026
Baxter Healthcare CorporationLABETALOL HYDROCHLORIDE 5 mg/mLJul 15, 2026Aug 28, 2026

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

Cite this page

DrugDashboards, "Labetalol Hydrochloride — NDC 70121-2428-03," retrieved September 3, 2026, https://drugdashboards.com/drug/70121242803.

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