Labetalol Hydrochloride Injection, Solution
NDC Package 65145-124-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Labetalol Hydrochloride injection is labetalol hydrochloride injection is indicated for control of blood pressure in severe hypertension. This formulation utilizes a injection, solution delivery system. Marketed by Caplin Steriles Limited, this product is identified by NDC 65145-124 and is authorized under FDA application ANDA214533.

Identification & Billing

NDC Package Code
65145-124-01
Package Description
1 VIAL, MULTI-DOSE in 1 CARTON / 20 mL in 1 VIAL, MULTI-DOSE
Product Code
65145-124
11-Digit Billing Format
65145012401
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Labetalol Hydrochloride
Non-Proprietary Name
Labetalol Hydrochloride
Substance Name
Labetalol Hydrochloride
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
LABETALOL HYDROCHLORIDE 5 mg/mL
Pharmacologic Class
Usage Information
Labetalol hydrochloride injection is indicated for control of blood pressure in severe hypertension.

Regulatory & Marketing

Labeler Name
Caplin Steriles Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA214533
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-14-2025
Listing Expiration
12-31-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 65145-124-01 identifies a specific commercial package of 1 vial, multi-dose in 1 carton / 20 ml in 1 vial, multi-dose of Labetalol Hydrochloride, a human prescription drug labeled by Caplin Steriles Limited. This injection, solution is formulated for intravenous 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 Caplin Steriles Limited on February 14, 2025. The current certification is valid through December 31, 2026.

How is this Caplin Steriles Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65145012401. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
65145-124-01
11-Digit CMS (5-4-2)
65145-0124-01

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