Product Information
LABETALOL HCL 300 MG TABLET is a generic product labeled by Zydus Pharmaceuticals (USA) Inc., priced at $0.2146 per EA under NDC 68382080005. Its NADAC has been published 439 times since May 9, 2018.
FDA first approved this application on Sep 19, 2017. Its Orange Book therapeutic-equivalence code is AB — FDA rates it therapeutically equivalent to (substitutable for) its reference product.
Strength
300 mg/1
Manufacturer
Zydus Pharmaceuticals (USA) Inc.NDC
68382080005
Classification
Generic
Dosage Form
TABLET, FILM COATED
Route
ORAL
Effective Date
9/23/2026
Active Ingredients
LABETALOL HYDROCHLORIDEApproval Type
Generic (ANDA)
FDA Application
ANDA207743FDA Approved
9/19/2017
TE Code
AB
On Market Since
12/5/2017
Pharmacological Classes
Price Statistics
The NADAC for LABETALOL HCL 300 MG TABLET has been published 439 times since May 9, 2018, and over the history we have for it it has declined 38.4%. The table below summarizes its recorded NADAC range and movement.
| Current price | $0.2146 per EA |
|---|---|
| All-time high | $0.3525 (Jun 13, 2018) |
| All-time low | $0.1776 (Nov 20, 2024) |
| 52-week high | $0.2157 |
| 52-week low | $0.2041 |
| Median price | $0.2211 |
| Average price | $0.2413 |
| Largest weekly change | +21.9% (Feb 17, 2021) |
| Weeks tracked | 439 |
| Tracking since | May 9, 2018 |
Generic Alternatives
The matcher finds 12 manufacturers 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). Switching to the cheapest would cut per-unit acquisition cost by roughly 5% at current NADAC. These are candidates to verify clinically, not guaranteed substitutes — see our generic drug prices guide.
Related Drugs
Same classification
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Manufacturer
Zydus Pharmaceuticals (USA) Inc. manufacturer profile
See the full portfolio, pricing trend, and other products from this labeler.
Drug market
Labetalol Hydrochloride market comparison
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Therapeutic class
beta-Adrenergic Blocker class view
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Trend hub
Latest market trends
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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 300 MG TABLET?
The current National Average Drug Acquisition Cost (NADAC) for LABETALOL HCL 300 MG TABLET, manufactured by Zydus Pharmaceuticals (USA) Inc., is $0.2146 per EA (NDC 68382080005), effective Sep 30, 2026.
How has the price of LABETALOL HCL 300 MG TABLET changed over time?
Over the history we have for it, the NADAC for LABETALOL HCL 300 MG TABLET has declined 38.4%. It has been tracked across 439 weekly CMS publications since May 9, 2018.
What are the highest and lowest recorded NADAC prices for LABETALOL HCL 300 MG TABLET?
Since May 9, 2018, the NADAC for LABETALOL HCL 300 MG TABLET has ranged from a low of $0.1776 (Nov 20, 2024) to a high of $0.3525 (Jun 13, 2018), with a median of $0.2211 per EA.
Are there cheaper alternatives to LABETALOL HCL 300 MG TABLET?
Yes. 12 manufacturers publish a NADAC-priced product with the same active ingredient and strength in a comparable dosage form. The lowest-priced option, LABETALOL HCL 300 MG TABLET, is $0.2041 per EA — about 5% below LABETALOL HCL 300 MG TABLET.
Who manufactures LABETALOL HCL 300 MG TABLET?
LABETALOL HCL 300 MG TABLET (NDC 68382080005) is labeled by Zydus Pharmaceuticals (USA) Inc., and CMS classifies it as a generic product.