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Labetalol Hydrochloride

Labetalol · LABETALOL 100 mg/1 · Tablet, Film Coated · Oral · Marlex Pharmaceuticals Inc

NDC 10135-0711-01 · 100 TABLET, FILM COATED in 1 BOTTLE · ANDA · View full market →

The short version

Only one company currently supplies this market — there is no backup if it stumbles.

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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.

Regulatory

Application
ANDA075215
TE code
AB
Approval date
Jul 29, 1999
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 (Tablet, Film Coated)

LabelerStrengthFirst seenLast seen
Marlex Pharmaceuticals IncLABETALOL 100 mg/1Jul 15, 2026Sep 2, 2026
Marlex Pharmaceuticals IncLABETALOL 200 mg/1Jul 15, 2026Sep 2, 2026
Marlex Pharmaceuticals IncLABETALOL 300 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 10135-0711-01," retrieved September 3, 2026, https://drugdashboards.com/drug/10135071101.

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