Labetalol Hydrochloride Tablet, Film Coated
NDC Package 29300-252-01

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 uSP are indicated in the management of hypertension. This formulation utilizes a tablet, film coated delivery system. Marketed by Unichem Pharmaceuticals (usa), Inc., this product is identified by NDC 29300-252 and is authorized under FDA application ANDA212719.

Identification & Billing

NDC Package Code
29300-252-01
Package Description
100 TABLET, FILM COATED in 1 BOTTLE
Product Code
29300-252
11-Digit Billing Format
29300025201
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 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.

Regulatory & Marketing

Labeler Name
Unichem Pharmaceuticals (usa), Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA212719
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-01-2022
Listing Expiration
12-31-2027
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 (29300-252). Click a package code to view its specific billing and regulatory data.

29300-252-05
500 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 29300-252-01 identifies a specific commercial package of 100 tablet, film coated in 1 bottle of Labetalol Hydrochloride, a human prescription drug labeled by Unichem Pharmaceuticals (usa), Inc.. 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 Unichem Pharmaceuticals (usa), Inc. on October 01, 2022. The current certification is valid through December 31, 2027.

How is this Unichem Pharmaceuticals (usa), Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 29300025201. 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)
29300-252-01
11-Digit CMS (5-4-2)
29300-0252-01

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