DrugDashboards

Labetalol Hydrochloride

Labetalol Hydrochloride · LABETALOL HYDROCHLORIDE 5 mg/mL · Injection, Solution · Intravenous · Hospira, Inc.

NDC 00409-0125-25 · 25 VIAL, MULTI-DOSE in 1 TRAY / 20 mL in 1 VIAL, MULTI-DOSE · 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
$99.00
Reported to Texas DSHS · 2026 annual filing · Pfizer Inc.

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%

Medicaid spend (2025)

$1,663
534 prescriptions paid by Medicaid nationally · all Medicaid spend →

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
ANDA075240
TE code
AP
Approval date
Nov 29, 1999
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class II · TerminatedFeb 20, 2018
    Hospira Inc. A Pfizer Company — Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal.
  • Class II · TerminatedMay 16, 2014
    Hospira Inc. — Presence of Particulate Matter; metal embedded in the glass vial and visible particles floating in the solution

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 00409-0125-25," retrieved September 3, 2026, https://drugdashboards.com/drug/00409012525.

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