DrugDashboards

Labetalol Hydrochloride

Labetalol Hydrochloride · LABETALOL HYDROCHLORIDE 200 mg/1 · Tablet, Film Coated · Oral · Bryant Ranch Prepack

NDC 71335-2169-01 · 30 TABLET, FILM COATED in 1 BOTTLE · ANDA · View full market →

The short version

15 companies supply this market — deep enough that no single failure threatens the supply.

The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 68001-0382-00) — same generic, strength, and dosage form. CMS prices one NDC per drug concept, not every package.

ⓘ How this was built
Data sources
  • CMS quarterly Prescription Drug Plan Formulary & Pricing files (SPUF)
Method

Negotiated 30-day point-of-sale unit prices and formulary terms aggregated across every unsuppressed Part D and MA-PD plan for the quarter shown. Point of sale means gross of confidential rebates. CMS publishes one representative NDC per drug concept (RxCUI) rather than every package, so these figures come from CMS's representative package for the same drug — matched on generic name, strength, and dosage form. Estimated from MedPAC's program-wide rebate aggregates (June 2023: DIR = 29% of gross Part D spending; brand rebates ≈ 25–40% of gross, generics minimal). Actual rebates are confidential and vary widely by drug — this is a range, not a fact about this drug.

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

Plans pay at point of sale
$0.2577per unit
middle half $0.1194$0.3251 · 5,496 plans · Apr 1, 2026
Est. net of rebates
≈ $0.2577
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
100%of plans cover it
tier 2 · prior auth 0% · step therapy 0% · qty limit 0%

*No drug-level rebate is public — the estimate applies MedPAC's program-wide brand rebate range to this drug's gross price. Tracked here for 2 quarters since 2024.

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 →

Where it's made

Establishments this product's FDA label declares, located via FDA registration data. How we built this →

Regulatory

Application
ANDA211953
TE code
AB
Approval date
Aug 18, 2021
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, Film Coated)

LabelerStrengthFirst seenLast seen
A-S Medication SolutionsLABETALOL HYDROCHLORIDE 100 mg/1Jul 15, 2026Sep 3, 2026
A-S Medication SolutionsLABETALOL HYDROCHLORIDE 200 mg/1Jul 15, 2026Sep 3, 2026
A-S Medication SolutionsLABETALOL HYDROCHLORIDE 300 mg/1Jul 15, 2026Sep 3, 2026
Actavis Pharma, Inc.LABETALOL HYDROCHLORIDE 100 mg/1Jul 15, 2026Sep 3, 2026
Advagen Pharma LtdLABETALOL HYDROCHLORIDE 300 mg/1Jul 15, 2026Sep 3, 2026
Bryant Ranch PrepackLABETALOL 300 mg/1Jul 15, 2026Sep 3, 2026
Bryant Ranch PrepackLABETALOL 200 mg/1Jul 15, 2026Sep 3, 2026
Bryant Ranch PrepackLABETALOL HYDROCHLORIDE 200 mg/1Jul 15, 2026Sep 3, 2026
Bryant Ranch PrepackLABETALOL HYDROCHLORIDE 100 mg/1Jul 15, 2026Sep 3, 2026
Bryant Ranch PrepackLABETALOL 100 mg/1Jul 15, 2026Sep 3, 2026
Cardinal Health 107, LLCLABETALOL HYDROCHLORIDE 200 mg/1Jul 15, 2026Sep 3, 2026
Method Pharmaceuticals, LLCLABETALOL 300 mg/1Jul 15, 2026Sep 3, 2026
Proficient Rx LPLABETALOL HYDROCHLORIDE 100 mg/1Jul 15, 2026Sep 3, 2026
St. Mary's Medical Park PharmacyLABETALOL HYDROCHLORIDE 100 mg/1Jul 15, 2026Sep 3, 2026
Advagen Pharma LtdLABETALOL HYDROCHLORIDE 100 mg/1Jul 15, 2026Sep 2, 2026
Advagen Pharma LtdLABETALOL HYDROCHLORIDE 200 mg/1Jul 15, 2026Sep 2, 2026
American Health PackagingLABETALOL HYDROCHLORIDE 200 mg/1Jul 15, 2026Sep 2, 2026
American Health PackagingLABETALOL HYDROCHLORIDE 300 mg/1Jul 15, 2026Sep 2, 2026
American Health PackagingLABETALOL HYDROCHLORIDE 100 mg/1Jul 15, 2026Sep 2, 2026
Biocon Pharma Inc.LABETALOL HYDROCHLORIDE 400 mg/1Jul 15, 2026Sep 2, 2026
Biocon Pharma Inc.LABETALOL HYDROCHLORIDE 300 mg/1Jul 15, 2026Sep 2, 2026
Biocon Pharma Inc.LABETALOL HYDROCHLORIDE 100 mg/1Jul 15, 2026Sep 2, 2026
Biocon Pharma Inc.LABETALOL HYDROCHLORIDE 200 mg/1Jul 15, 2026Sep 2, 2026
BluePoint Laboratories Inc.LABETALOL HYDROCHLORIDE 100 mg/1Jul 15, 2026Sep 2, 2026
BluePoint Laboratories Inc.LABETALOL HYDROCHLORIDE 200 mg/1Jul 15, 2026Sep 2, 2026
BluePoint Laboratories Inc.LABETALOL HYDROCHLORIDE 300 mg/1Jul 15, 2026Sep 2, 2026
Bryant Ranch PrepackLABETALOL HYDROCHLORIDE 300 mg/1Jul 15, 2026Sep 2, 2026
Cadila Pharmaceuticals LimitedLABETALOL HYDROCHLORIDE 100 mg/1Jul 15, 2026Sep 2, 2026
Cadila Pharmaceuticals LimitedLABETALOL HYDROCHLORIDE 200 mg/1Jul 15, 2026Sep 2, 2026
Cadila Pharmaceuticals LimitedLABETALOL HYDROCHLORIDE 300 mg/1Jul 15, 2026Sep 2, 2026
Cardinal Health 107, LLCLABETALOL HYDROCHLORIDE 300 mg/1Jul 15, 2026Sep 2, 2026
Golden State Medical Supply, Inc.LABETALOL HYDROCHLORIDE 100 mg/1Jul 15, 2026Sep 2, 2026
Golden State Medical Supply, Inc.LABETALOL HYDROCHLORIDE 300 mg/1Jul 15, 2026Sep 2, 2026
Golden State Medical Supply, Inc.LABETALOL HYDROCHLORIDE 200 mg/1Jul 15, 2026Sep 2, 2026
Innogenix, Inc.LABETALOL HYDROCHLORIDE 300 mg/1Jul 15, 2026Sep 2, 2026
Innogenix, Inc.LABETALOL HYDROCHLORIDE 100 mg/1Jul 15, 2026Sep 2, 2026
Innogenix, Inc.LABETALOL HYDROCHLORIDE 200 mg/1Jul 15, 2026Sep 2, 2026
Macleods Pharmaceuticals LimitedLABETALOL HYDROCHLORIDE 100 mg/1Jul 15, 2026Sep 2, 2026
Macleods Pharmaceuticals LimitedLABETALOL HYDROCHLORIDE 200 mg/1Jul 15, 2026Sep 2, 2026
Macleods Pharmaceuticals LimitedLABETALOL HYDROCHLORIDE 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 71335-2169-01," retrieved September 3, 2026, https://drugdashboards.com/drug/71335216901.

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