Labetalol Hydrochloride Tablet, Film Coated
NDC Package 33342-515-15

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Labetalol Hydrochloride tablets is labetalol Hydrochloride is indicated in the management of hypertension, to lower blood pressure. This formulation utilizes a tablet, film coated delivery system. Marketed by Macleods Pharmaceuticals Limited, this product is identified by NDC 33342-515 and is authorized under FDA application ANDA217949.

Identification & Billing

NDC Package Code
33342-515-15
Package Description
500 TABLET, FILM COATED in 1 BOTTLE
Product Code
33342-515
11-Digit Billing Format
33342051515
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Labetalol Hydrochloride
Non-Proprietary Name
Labetalol Hydrochloride
Substance Name
Labetalol Hydrochloride
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
LABETALOL HYDROCHLORIDE 100 mg/1
Pharmacologic Class
Usage Information
Labetalol Hydrochloride is indicated in the management of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including beta adrenergic blockers.                                                                      Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive  treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.Labetalol Hydrochloride Tablets may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.

Regulatory & Marketing

Labeler Name
Macleods Pharmaceuticals Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA217949
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-23-2025
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (33342-515). Click a package code to view its specific billing and regulatory data.

33342-515-11
100 TABLET, FILM COATED in 1 BOTTLE

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 33342-515-15 identifies a specific commercial package of 500 tablet, film coated in 1 bottle of Labetalol Hydrochloride, a human prescription drug labeled by Macleods Pharmaceuticals Limited. This tablet, film coated is formulated for oral use and contains labetalol hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Macleods Pharmaceuticals Limited on September 23, 2025. The current certification is valid through December 31, 2026.

How is this Macleods Pharmaceuticals Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 33342051515. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
33342-515-15
11-Digit CMS (5-4-2)
33342-0515-15

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.