Labetalol Hydrochloride
NDC Package 54868-4921-3

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 inactivated by the FDA.

Labetalol Hydrochloride is labetalol HCl tablets are indicated in the management of hypertension. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-4921 and is authorized under FDA application ANDA074787.

Identification & Billing

NDC Package Code
54868-4921-3
Package Description
180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code
54868-4921
11-Digit Billing Format
54868492103
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Labetalol Hydrochloride
Dosage Form
-
Usage Information
Labetalol HCl tablets are indicated in the management of hypertension. Labetalol HCl tablets may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
ANDA074787
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-06-2004
Listing Expiration
12-31-2017
Exclude Flag
I
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 (54868-4921). Click a package code to view its specific billing and regulatory data.

54868-4921-0
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
54868-4921-1
100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
54868-4921-2
60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
54868-4921-4
120 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 54868-4921-3 identifies a specific commercial package of 180 tablet, film coated in 1 bottle, plastic of Labetalol Hydrochloride, labeled by Physicians Total Care, 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 Physicians Total Care, Inc. on May 06, 2004. The current certification is valid through December 31, 2017.

How is this Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868492103. 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 (5-4-1)
54868-4921-3
11-Digit CMS (5-4-2)
54868-4921-03

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