Labetalol Hydrochloride
NDC Package 71930-035-52

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 a . Marketed by Eywa Pharma Inc, this product is identified by NDC 71930-035 and is authorized under FDA application ANDA207863.

Identification & Billing

NDC Package Code
71930-035-52
Package Description
500 TABLET, FILM COATED in 1 BOTTLE
Product Code
71930-035
11-Digit Billing Format
71930003552
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
500 EA

Clinical Specifications

Proprietary Name
Labetalol Hydrochloride
Dosage Form
-

Regulatory & Marketing

Labeler Name
Eywa Pharma Inc
FDA Application #
ANDA207863
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-24-2019
End Marketing Date
04-30-2024
Listing Expiration
04-30-2024
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 (71930-035). Click a package code to view its specific billing and regulatory data.

71930-035-12
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 71930-035-52 identifies a specific commercial package of 500 tablet, film coated in 1 bottle of Labetalol Hydrochloride, labeled by Eywa 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 Eywa Pharma Inc on May 24, 2019. The current certification is valid through April 30, 2024.

How is this Eywa Pharma Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71930003552. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 500 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 (5-3-2)
71930-035-52
11-Digit CMS (5-4-2)
71930-0035-52

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