LABETALOL HYDROCHLORIDE 5 mg/mL
labetalol hydrochloride · INJECTION, SOLUTION · Amneal Pharmaceuticals LLC
LABETALOL HYDROCHLORIDE is a injection, solution containing labetalol hydrochloride at 5 mg/mL, taken intravenous. Manufactured by Amneal Pharmaceuticals LLC.
Key Facts
- Brand Name
- LABETALOL HYDROCHLORIDE
- Generic Name
- labetalol hydrochloride
- NDC Code (Product)
70121-2428- Manufacturer
- Amneal Pharmaceuticals LLC
- Strength
- 5 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA218870
- Marketing Start
- 10/02/2025
Recall History
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Hospira Inc. A Pfizer Company
Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal.
Hospira Inc.
Presence of Particulate Matter; metal embedded in the glass vial and visible particles floating in the solution
Pfizer Inc.
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Labetalol 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.
Dosage & Administration
DOSAGE AND ADMINISTRATION DOSAGE MUST BE INDIVIDUALIZED. The recommended initial dosage is 100 mg twice daily whether used alone or added to a diuretic regimen. After 2 or 3 days, using standing blood pressure as an indicator, dosage may be titrated in increments of 100 mg b.i.d.(twice daily) every 2 or 3 days. The usual maintenance dosage of labetalol hydrochloride tablets is between 200 mg and 400 mg twice daily. Since the full antihypertensive effect of labetalol hydrochloride tablets is usually seen within the first 1 to 3 hours of the initial dose or dose increment, the assurance of a lack of an exaggerated hypotensive response can be clinically established in the office setting. The antihypertensive effects of continued dosing can be measured at subsequent visits, approximately 12 hours after a dose, to determine whether further titration is necessary. Patients with severe hypertension may require from 1200 mg to 2400 mg per day, with or without thiazide diuretics. Should side effects (principally nausea or dizziness) occur with these doses administered b.i.d.(twice daily), the same total daily dose administered t.i.d. (three times daily) may improve tolerability and facilita…
Warnings
WARNINGS Hepatic Injury Severe hepatocellular injury, confirmed by rechallenge in at least one case, occurs rarely with labetalol therapy. The hepatic injury is usually reversible, but hepatic necrosis and death have been reported. Injury has occurred after both short- and long-term treatment and may be slowly progressive despite minimal symptomatology. Similar hepatic events have been reported with a related research compound, dilevalol HCl, including two deaths. Dilevalol HCl is one of the four isomers of labetalol hydrochloride. Thus, for patients taking labetalol, periodic determination of suitable hepatic laboratory tests would be appropriate. Appropriate laboratory testing should be done at the first symptom or sign of liver dysfunction (e.g., pruritus, dark urine, persistent anorexia, jaundice, right upper quadrant tenderness, or unexplained "flu-like" symptoms). If the patient has laboratory evidence of liver injury or jaundice, labetalol should be stopped and not restarted. Cardiac Failure Sympathetic stimulation is a vital component supporting circulatory function in congestive heart failure. Beta-blockade carries a potential hazard of further depressing myocardial contra…
Contraindications
CONTRAINDICATIONS Labetalol hydrochloride is contraindicated in bronchial asthma, overt cardiac failure, greater-than-first-degree heart block, cardiogenic shock, severe bradycardia, other conditions associated with severe and prolonged hypotension, and in patients with a history of hypersensitivity to any component of the product [see Warnings] . Beta-blockers, even those with apparent cardioselectivity, should not be used in patients with a history of obstructive airway disease, including asthma.
Adverse Reactions
ADVERSE REACTIONS Most adverse effects are mild and transient and occur early in the course of treatment. In controlled clinical trials of 3 to 4 months' duration, discontinuation of labetalol hydrochloride due to one or more adverse effects was required in 7% of all patients. In these same trials, other agents with solely beta-blocking activity used in the control groups led to discontinuation in 8% to 10% of patients, and a centrally acting alpha-agonist led to discontinuation in 30% of patients. The incidence rates of adverse reactions listed in the following table were derived from multicenter, controlled clinical trials comparing labetalol hydrochloride, placebo, metoprolol, and propranolol over treatment periods of 3 and 4 months. Where the frequency of adverse effects for labetalol hydrochloride and placebo is similar, causal relationship is uncertain. The rates are based on adverse reactions considered probably drug related by the investigator. If all reports are considered, the rates are somewhat higher (e.g., dizziness, 20%; nausea, 14%; fatigue, 11%), but the overall conclusions are unchanged. Labetalol Hydrochloride (N=227) % Placebo (N=98) % Propranolol (N=84) % Metopr…
Frequently Asked Questions
What is LABETALOL HYDROCHLORIDE used for?
LABETALOL HYDROCHLORIDE contains labetalol hydrochloride. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is LABETALOL HYDROCHLORIDE a controlled substance?
LABETALOL HYDROCHLORIDE is not classified as a controlled substance by the DEA.
What is the generic name for LABETALOL HYDROCHLORIDE?
The generic name for LABETALOL HYDROCHLORIDE is labetalol hydrochloride. There are 12 other brand versions of labetalol hydrochloride.
What is the NDC code for LABETALOL HYDROCHLORIDE 5 mg/mL?
The NDC (National Drug Code) for LABETALOL HYDROCHLORIDE 5 mg/mL is 70121-2428, listed by Amneal Pharmaceuticals LLC.
Other Labetalol Brands
See all →- Labetalol Hydrochloride100 mg/172162-1675
- Labetalol Hydrochloride300 mg/10904-7453
- labetalol hydrochloride5 mg/mL25021-317
- Labetalol HCl in Sodium Chloride1 mg/mL0143-9363
- Labetalol HCl in Sodium Chloride1 mg/mL0143-9364
- Labetalol Hydrochloride100 mg/150090-7458
- Labetalol Hydrochloride200 mg/155154-2143
- Labetalol Hydrochloride300 mg/158657-604
- Labetalol Hydrochloride300 mg/162135-800
- Labetalol Hydrochloride200 mg/163629-2053
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)