Adasuve Aerosol, Powder
NDC Package 51097-001-02

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

Package Information

Adasuve (loxapine) aerosols is aDASUVE is indicated for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults [see Clinical Studies (14)]. This formulation utilizes a aerosol, powder delivery system. Marketed by Alexza Pharmaceuticals, Inc., this product is identified by NDC 51097-001 and is authorized under FDA application NDA022549.

Identification & Billing

NDC Package Code
51097-001-02
Package Description
5 INHALER in 1 CARTON / 1 AEROSOL, POWDER in 1 INHALER (51097-001-01)
Product Code
51097-001
11-Digit Billing Format
51097000102
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
5 EA

Clinical Specifications

Proprietary Name
Adasuve
Non-Proprietary Name
Loxapine
Substance Name
Loxapine
Dosage Form
Aerosol, Powder - A product that is packaged under pressure and contains therapeutically active ingredients, in the form of a powder, that are released upon activation of an appropriate valve system.
Administration Route
Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
Active Ingredient(s)
LOXAPINE 10 mg/1
Usage Information
ADASUVE is indicated for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults [see Clinical Studies (14)] .

Regulatory & Marketing

Labeler Name
Alexza Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA022549
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-06-2026
Listing Expiration
12-31-2027
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 51097-001-02 identifies a specific commercial package of 5 inhaler in 1 carton / 1 aerosol, powder in 1 inhaler (51097-001-01) of Adasuve, a human prescription drug labeled by Alexza Pharmaceuticals, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 5 billable units per package. This aerosol, powder is formulated for respiratory (inhalation) use and contains loxapine 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 Alexza Pharmaceuticals, Inc. on July 06, 2026. The current certification is valid through December 31, 2027.

How is this Alexza Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51097000102. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 5 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)
51097-001-02
11-Digit CMS (5-4-2)
51097-0001-02

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