DrugDashboards

Labetalol Hydrochloride

Labetalol Hydrochloride · LABETALOL HYDROCHLORIDE 200 mg/1 · Tablet · Oral · Epic Pharma, LLC

NDC 42806-0328-01 · 100 TABLET in 1 BOTTLE · ANDA · View full market →

The short version

6 companies supply this market — a reasonable cushion if one runs into trouble.

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.

Supply fragility

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

90-day shortage risk (model v2)

0.1%chance of a new FDA shortage posting for labetalol hydrochloride (oral solid) in the next 90 days

sole-source market · price up 2% YoY

For scale: the typical drug’s chance is about 0.1% — this one is in ordinary territory.

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

Regulatory

Application
ANDA212990
TE code
AB
Approval date
Sep 30, 2020
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 (Tablet)

LabelerStrengthFirst seenLast seen
BluePoint LaboratoriesLABETALOL HYDROCHLORIDE 100 mg/1Jul 15, 2026Sep 2, 2026
BluePoint LaboratoriesLABETALOL HYDROCHLORIDE 200 mg/1Jul 15, 2026Sep 2, 2026
BluePoint LaboratoriesLABETALOL HYDROCHLORIDE 300 mg/1Jul 15, 2026Sep 2, 2026
Chartwell RX, LLCLABETALOL HYDROCHLORIDE 200 mg/1Jul 15, 2026Sep 2, 2026
Chartwell RX, LLCLABETALOL HYDROCHLORIDE 100 mg/1Jul 15, 2026Sep 2, 2026
Chartwell RX, LLCLABETALOL HYDROCHLORIDE 300 mg/1Jul 15, 2026Sep 2, 2026
Coupler LLCLABETALOL HYDROCHLORIDE 100 mg/1Aug 26, 2026Sep 2, 2026
Epic Pharma, LLCLABETALOL HYDROCHLORIDE 100 mg/1Jul 15, 2026Sep 2, 2026
Epic Pharma, LLCLABETALOL HYDROCHLORIDE 200 mg/1Jul 15, 2026Sep 2, 2026
Epic Pharma, LLCLABETALOL HYDROCHLORIDE 300 mg/1Jul 15, 2026Sep 2, 2026
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.LABETALOL HYDROCHLORIDE 200 mg/1Jul 15, 2026Sep 2, 2026
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.LABETALOL HYDROCHLORIDE 100 mg/1Jul 15, 2026Sep 2, 2026
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.LABETALOL HYDROCHLORIDE 300 mg/1Jul 15, 2026Sep 2, 2026
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.LABETALOL HYDROCHLORIDE 400 mg/1Jul 15, 2026Sep 2, 2026
NorthStar Rx LLCLABETALOL HYDROCHLORIDE 100 mg/1Jul 15, 2026Sep 2, 2026
NorthStar Rx LLCLABETALOL HYDROCHLORIDE 300 mg/1Jul 15, 2026Sep 2, 2026
NorthStar Rx LLCLABETALOL HYDROCHLORIDE 200 mg/1Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Labetalol Hydrochloride — NDC 42806-0328-01," retrieved September 3, 2026, https://drugdashboards.com/drug/42806032801.

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