Labetalol Hydrochloride Aerosol
NDC Package 66112-921-03

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Labetalol Hydrochloride aerosols is a drug for further processing. This formulation utilizes a aerosol delivery system. Marketed by Piramal Pharma Limited, this product is identified by NDC 66112-921.

Identification & Billing

NDC Package Code
66112-921-03
Package Description
500 AEROSOL in 1 BOTTLE
Product Code
66112-921
11-Digit Billing Format
66112092103

Clinical Specifications

Proprietary Name
Labetalol Hydrochloride
Non-Proprietary Name
Labetalol Hydrochloride
Substance Name
Labetalol Hydrochloride
Dosage Form
Aerosol - A product that is packaged under pressure and contains therapeutically active ingredients that are released upon activation of an appropriate valve system; it is intended for topical application to the skin as well as local application into the nose (nasal aerosols), mouth (lingual aerosols), or lungs (inhalation aerosols).
Active Ingredient(s)
LABETALOL HYDROCHLORIDE 300 mg/1

Regulatory & Marketing

Labeler Name
Piramal Pharma Limited
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
12-22-2025
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 (66112-921). Click a package code to view its specific billing and regulatory data.

66112-921-01
30 AEROSOL in 1 BOTTLE
66112-921-02
100 AEROSOL 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 66112-921-03 identifies a specific commercial package of 500 aerosol in 1 bottle of Labetalol Hydrochloride (UNFINISHED drug), drug for further processing labeled by Piramal Pharma Limited. This aerosol is formulated for 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 Piramal Pharma Limited on December 22, 2025. The current certification is valid through December 31, 2026.

How is this Piramal Pharma Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 66112092103. 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)
66112-921-03
11-Digit CMS (5-4-2)
66112-0921-03

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