Product Information

LABETALOL HCL 400 MG TABLET is a generic product labeled by Biocon Pharma Inc., priced at $1.5181 per EA under NDC 70377006312. Its NADAC has been published 36 times since Dec 17, 2025.

FDA first approved this application on Jun 20, 2018. Its Orange Book therapeutic-equivalence code is AB — FDA rates it therapeutically equivalent to (substitutable for) its reference product.

The High Outlier badge above means this manufacturer's average price in the Labetalol Hydrochloride market falls above Q3 + 1.5·IQR across all competing manufacturers. We only apply this flag in markets with four or more competitors. Full definition: glossary → outlier.

LABETALOL HCL 400 MG TABLET

Labetalol Hydrochloride
$1.5181per EA
High Outlier

Strength

400 mg/1

Manufacturer

Biocon Pharma Inc.

NDC

70377006312

Classification

Generic

Dosage Form

TABLET, FILM COATED

Route

ORAL

Effective Date

8/19/2026

Active Ingredients

LABETALOL HYDROCHLORIDE

Approval Type

Generic (ANDA)

FDA Application

ANDA209603

FDA Approved

6/20/2018

TE Code

AB

On Market Since

12/2/2024

Pharmacological Classes

Adrenergic beta-Antagonists
beta-Adrenergic Blocker

Price Statistics

The NADAC for LABETALOL HCL 400 MG TABLET has been published 36 times since Dec 17, 2025, and over the history we have for it it has risen 3.9%. The table below summarizes its recorded NADAC range and movement.

Current price$1.5181 per EA
All-time high$1.5526 (Jun 10, 2026)
All-time low$1.4618 (Dec 17, 2025)
52-week high$1.5526
52-week low$1.4618
Median price$1.4618
Average price$1.4851
Largest weekly change+6.2% (May 20, 2026)
Weeks tracked36
Tracking sinceDec 17, 2025

Price History

1W

+1.4%

1M

+1.4%

3M

-2.2%

6M

+3.9%

1Y

N/A

3Y

N/A

5Y

N/A

All

+3.9%

Generic Alternatives

The matcher finds 1 manufacturer offering a NADAC-published product with this drug's active ingredient and strength in a comparable dosage form (cheapest from each manufacturer, up to 10 shown below). None of the shown alternatives sit below the current price. These are candidates to verify clinically, not guaranteed substitutes — see our generic drug prices guide.

Lowest-Cost Alternatives

1 alternative • Same active ingredient

Frequently asked questions

What is the NADAC price of LABETALOL HCL 400 MG TABLET?

The current National Average Drug Acquisition Cost (NADAC) for LABETALOL HCL 400 MG TABLET, manufactured by Biocon Pharma Inc., is $1.5181 per EA (NDC 70377006312), effective Aug 19, 2026.

How has the price of LABETALOL HCL 400 MG TABLET changed over time?

Over the history we have for it, the NADAC for LABETALOL HCL 400 MG TABLET has risen 3.9%. It has been tracked across 36 weekly CMS publications since Dec 17, 2025.

What are the highest and lowest recorded NADAC prices for LABETALOL HCL 400 MG TABLET?

Since Dec 17, 2025, the NADAC for LABETALOL HCL 400 MG TABLET has ranged from a low of $1.4618 (Dec 17, 2025) to a high of $1.5526 (Jun 10, 2026), with a median of $1.4618 per EA.

Are there cheaper alternatives to LABETALOL HCL 400 MG TABLET?

1 manufacturer publishes a NADAC-priced product with the same active ingredient and strength as LABETALOL HCL 400 MG TABLET in a comparable dosage form, but none are currently priced below it.

Who manufactures LABETALOL HCL 400 MG TABLET?

LABETALOL HCL 400 MG TABLET (NDC 70377006312) is labeled by Biocon Pharma Inc., and CMS classifies it as a generic product.