Product Information
LABETALOL HCL 400 MG TABLET is a generic product labeled by Biocon Pharma Inc., priced at $1.5525 per EA under NDC 70377006312. Its NADAC has been published 42 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.
Strength
400 mg/1
Manufacturer
Biocon Pharma Inc.NDC
70377006312
Classification
Generic
Dosage Form
TABLET, FILM COATED
Route
ORAL
Effective Date
9/23/2026
Active Ingredients
LABETALOL HYDROCHLORIDEApproval Type
Generic (ANDA)
FDA Application
ANDA209603FDA Approved
6/20/2018
TE Code
AB
On Market Since
12/2/2024
Pharmacological Classes
Price Statistics
The NADAC for LABETALOL HCL 400 MG TABLET has been published 42 times since Dec 17, 2025, and over the history we have for it it has risen 6.2%. The table below summarizes its recorded NADAC range and movement.
| Current price | $1.5525 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 | $1.4915 |
| Largest weekly change | +6.2% (May 20, 2026) |
| Weeks tracked | 42 |
| Tracking since | Dec 17, 2025 |
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.
Related Drugs
Same classification
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Manufacturer
Biocon Pharma Inc. manufacturer profile
See the full portfolio, pricing trend, and other products from this labeler.
Drug market
Labetalol Hydrochloride market comparison
Compare this molecule across participating manufacturers and inspect the broader market price spread.
Therapeutic class
beta-Adrenergic Blocker class view
See how this drug behaves alongside other products in the same FDA pharmacologic class.
Trend hub
Latest market trends
Zoom back out to the weekly mover view and compare this NDC with the rest of the current NADAC release.
Guide
Understanding NADAC pricing
Use the explainer when you need context on how CMS publishes NADAC and how to interpret the number on this page.
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 $1.5525 per EA (NDC 70377006312), effective Sep 30, 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 6.2%. It has been tracked across 42 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.