DrugDashboards

Labetalol Hydrochloride

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

NDC 00409-2339-34 · 10 CARTON in 1 PACKAGE / 1 CARTRIDGE in 1 CARTON / 4 mL in 1 CARTRIDGE · 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.

One drug, every price

The same NDC has different prices depending on who is paying. Units differ between rungs — compare within a rung over time, not rung against rung, unless the units match.

ⓘ How this was built
Data sources
  • CMS NADAC (pharmacy acquisition, weekly)
  • CMS Part B ASP quarterly payment limits
  • CMS Maximum Fair Prices (IRA negotiated, NDC-level)
  • Medicare Part D Spending by Drug (data.cms.gov, name-matched)
  • VA FSS / Big4 federal contract prices (va.gov, twice monthly)
  • ACA Federal Upper Limits + weighted AMP (data.medicaid.gov, monthly)
  • California SB-17 WAC filings (list price, per package)
Method

Each rung is the newest figure for this NDC from one federal price system, shown with its own unit. Part D is matched by drug name because CMS publishes no NDCs there; it is gross spending, before confidential rebates.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

  • Medicare Part B pays (ASP+6%)$0.2180per billing unit (5 MG)HCPCS J1920 · Jul 1, 2026
  • Federal contracts pay (FSS)$85.83per package of 10X4MLPfizer Inc. · Jul 1, 2024
  • List price (WAC, as filed)$160.00per packagePfizer · Jan 1, 2026

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
$90.83
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)

$51,803
6,554 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 →

Where it's made

  • Hospira, Inc.United States
    analysis · label · manufacture · pack

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
ANDA075239
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 · OngoingMay 20, 2024
    Pfizer Inc. — Lack of Assurance of Sterility-The potential for incomplete crimp seals.

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 00409-2339-34," retrieved September 3, 2026, https://drugdashboards.com/drug/00409233934.

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