Prescription medicine
Labetalol First approved as Trandate
Labetalol (Trandate) is a prescription medicine with an FDA approval on record since 1984. FDA's NDC Directory lists it from 43 generic labelers, and pharmacies paid $0.215 per labetalol HCl 300 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the labetalol FDA label on DailyMed (effective March 2, 2026, Zydus Pharmaceuticals USA Inc.); the NDA 18716 record on Drugs@FDA; every labetalol label on DailyMed.
Highlights of the record
FDA label of March 2, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageLabetalol hydrochloride tablets, USP are indicated in the management of hypertension.
Forms and strengths
- 100 mg
- 200 mg
- 300 mg
- 400 mg
- 1 mg/ml
- 5 mg/ml
- 100 mg/20ml
- 200 mg/40ml
Film-coated tablet; tablet; injection; injection (solution).
On the market
- Earliest approval on file
- August 1, 1984 Trandate, Alvogen; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 26 first August 3, 1998; 20 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 43 of which 43 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.215 per tablet Labetalol HCl 300 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 6 since 2012 0 Class I among all firms' recalls; latest May 20, 2024; 8 more by firms not listed as its makers
- FAERS reports
- 13,250 through July 30, 2026
What is labetalol used for?
From the label: indications and usageLabetalol hydrochloride tablets, USP are indicated in the management of hypertension. Labetalol hydrochloride tablets USP may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.
Conditions named in the indications of labetalol's FDA labels, with every medicine labeled for each:
From other labetalol labelsHigh blood pressure: INDICATIONS AND USAGE Labetalol hydrochloride tablets, USP are indicated in the management of hypertension.
FDA pharmacologic class: beta-Adrenergic Blocker.
Source: FDA drug label (Labetalol Hydrochloride), Zydus Pharmaceuticals USA Inc., effective March 2, 2026 (SPL set 5942a5a8-c3c1-4ecb-921e-9bc92393bdf8), via openFDA; the full label on DailyMed
Is there a generic for labetalol (Trandate)?
The FDA approved the first generic labetalol on August 3, 1998. 26 generic applications are approved; 20 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists labetalol from 43 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1984 earliest approval on file
- 1998 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for labetalol (Trandate)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.215 per Labetalol HCl 300 mg tablet, up 3% from $0.208 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Labetalol HCl 300 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Labetalol HCl 100 mg tablet | Generic | $0.084 per tablet | $2.52 | +0.4% |
| Labetalol HCl 100 mg/20 mL vial | Generic | $0.185 per mL | n/a | +10% |
| Labetalol HCl 200 mg tablet | Generic | $0.140 per tablet | $4.19 | -5% |
| Labetalol HCl 300 mg tablet | Generic | $0.215 per tablet | $6.44 | +3% |
| Labetalol HCl 400 mg tablet | Generic | $1.55 per tablet | $46.58 | n/a |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has labetalol been recalled?
The FDA's Enforcement Report lists 14 recalls naming labetalol since 2012: 0 Class I (the most serious), 13 Class II, 1 Class III; 1 still ongoing. 8 of them are by firms that FDA's NDC Directory does not list as a maker of labetalol and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| May 20, 2024 | Class II | Pfizer Inc. | Lack of Assurance of Sterility-The potential for incomplete crimp seals. |
| November 9, 2023 | Class II | SCA Pharmaceuticals, LLC | Lack of Assurance of Sterility |
| June 30, 2022 | Class II | Nephron Sterile Compounding Center LLC not a listed maker | Lack of Assurance of Sterility |
| May 18, 2022 | Class II | Nephron Sterile Compounding Center LLC not a listed maker | Lack of Assurance of Sterility |
| April 13, 2022 | Class II | Mckesson Medical-Surgical Inc. Corporate Office | cGMP deviations: Temperature abuse |
| December 17, 2020 | Class II | SCA Pharmaceuticals not a listed maker | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit |
| September 12, 2019 | Class II | KRS Global Biotechnology, Inc not a listed maker | Lack of Assurance of Sterility |
| April 12, 2019 | Class II | CMC Enterprise Pharmacy not a listed maker | Lack of sterility assurance. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the labetalol label say about other medicines?
The labetalol label names 5 other medicines in its interaction, contraindication or warning sections. The labels of 2 other medicines name labetalol. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Amphetamine | drug interactions | When patients being treated with labetalol have a positive urine test for amphetamine using these techniques, confirmation should be made by using more specific methods, such as a gas chromatographic-mass spectrometer technique. |
| Cimetidine | drug interactions | Cimetidine has been shown to increase the bioavailability of labetalol hydrochloride. |
| Epinephrine | drug interactions | Such patients may be unresponsive to the usual doses of epinephrine used to treat allergic reaction. |
| Nitroglycerin | drug interactions | If labetalol hydrochloride is used with nitroglycerin in patients with angina pectoris, additional antihypertensive effects may occur. |
| Verapamil | drug interactions | Care should be taken if labetalol is used concomitantly with calcium antagonists of the verapamil type. |
Other labels that name labetalol
Source: FDA drug label (Labetalol Hydrochloride), Zydus Pharmaceuticals USA Inc., effective March 2, 2026 (SPL set 5942a5a8-c3c1-4ecb-921e-9bc92393bdf8), via openFDA; the full label on DailyMed
What do FAERS reports show for labetalol?
The FDA Adverse Event Reporting System holds 13,250 reports that list labetalol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,362 are coded as a death and 5,049 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as labetalol?
75 other medicines are given the same way (oral) and in the same FDA class as labetalol or labeled mainly for the same use (high blood pressure), the same class first. High blood pressure lists all 88 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Metoprolol | High blood pressure | 64 labelers | $0.085 per tablet 100 mg tablet | A presentation being discontinued |
| Propranolol | High blood pressure | 38 labelers | $0.0493 per tablet 20 mg tablet | In shortage |
| Carvedilol | High blood pressure | 41 labelers | $0.0179 per tablet 6.25 mg tablet | No current entry |
| Atenolol | High blood pressure | 35 labelers | $0.0217 per tablet 25 mg tablet | No current entry |
| Nebivolol | High blood pressure | 23 labelers | $0.141 per tablet 10 mg tablet | A presentation being discontinued |
| Nadolol | High blood pressure | 16 labelers | $0.147 per tablet 20 mg tablet | No current entry |
| Bisoprolol | High blood pressure | 24 labelers | $0.114 per tablet 5 mg tablet | No current entry |
| Bisoprolol and hydrochlorothiazide | High blood pressure | 11 labelers | $0.209 per tablet 10-6.25 mg tablet | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does labetalol compare with medicines for the same use?
15 side-by-side pages set labetalol beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to labetalol
- 75 medicines for the same use
- Other beta blockers
- the pharmacologic class, with prices and generics
- Labetalol side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other