Labetalol Hcl
NDC Package 0185-0010-01

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

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Labetalol Hcl is labetalol is used with or without other medications to treat high blood pressure (hypertension). Marketed by Eon Labs, Inc., this product is identified by NDC 0185-0010 and is authorized under FDA application ANDA075113.

Identification & Billing

NDC Package Code
0185-0010-01
Package Description
100 TABLET, FILM COATED in 1 BOTTLE
Product Code
0185-0010
11-Digit Billing Format
00185001001
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA

Clinical Specifications

Proprietary Name
Labetalol Hcl
Dosage Form
-
Usage Information
Labetalol is used with or without other medications to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. This medication is both an alpha blocker and beta blocker. It works by blocking the action of certain natural chemicals in your body such as epinephrine on the heart and blood vessels. This effect lowers the heart rate, blood pressure, and strain on the heart.

Regulatory & Marketing

Labeler Name
Eon Labs, Inc.
FDA Application #
ANDA075113
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-04-1998
End Marketing Date
09-30-2023
Listing Expiration
09-30-2023
Exclude Flag
D
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 (0185-0010). Click a package code to view its specific billing and regulatory data.

0185-0010-05
500 TABLET, FILM COATED in 1 BOTTLE
0185-0010-10
1000 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 0185-0010-01 identifies a specific commercial package of 100 tablet, film coated in 1 bottle of Labetalol Hcl, labeled by Eon Labs, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Eon Labs, Inc. on August 04, 1998. The current certification is valid through September 30, 2023.

What are the primary indications for this medication?

Labetalol is used with or without other medications to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. This medication is both an alpha blocker and beta blocker. It works by blocking the action of certain natural chemicals in your body such as epinephrine on the heart and blood vessels. This effect lowers the heart rate, blood pressure, and strain on the heart.

How is this Eon Labs, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00185001001. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 total billable units per package. 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 (4-4-2)
0185-0010-01
11-Digit CMS (5-4-2)
00185-0010-01

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