Labetalol Hydrochloride
NDC Package 0591-0607-01

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 Hydrochloride is tablets, USP are indicated in the management of hypertension. Marketed by Actavis Pharma, Inc., this product is identified by NDC 0591-0607 and is authorized under FDA application ANDA075133.

Identification & Billing

NDC Package Code
0591-0607-01
Package Description
100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code
0591-0607
11-Digit Billing Format
00591060701
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Labetalol Hydrochloride
Dosage Form
-
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
Actavis Pharma, Inc.
FDA Application #
ANDA075133
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-03-1998
End Marketing Date
05-31-2026
Listing Expiration
05-31-2026
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 (0591-0607). Click a package code to view its specific billing and regulatory data.

0591-0607-05
500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
0591-0607-10
1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

* 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 0591-0607-01 identifies a specific commercial package of 100 tablet, film coated in 1 bottle, plastic of Labetalol Hydrochloride, labeled by Actavis Pharma, 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 Actavis Pharma, Inc. on August 03, 1998. The current certification is valid through May 31, 2026.

How is this Actavis Pharma, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00591060701. 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)
0591-0607-01
11-Digit CMS (5-4-2)
00591-0607-01

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