Ammonia Inhalants Inhalant
NDC Package 85813-003-01

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

Package Information

Ammonia Inhalants (ammonia) inhalants is a medication used to treat or prevent fainting. This formulation utilizes a inhalant delivery system. Marketed by Direct Outlet Supplier Llc, this product is identified by NDC 85813-003 and is authorized under FDA application M011.

Identification & Billing

NDC Package Code
85813-003-01
Package Description
50 AMPULE in 1 BOX / .3 mL in 1 AMPULE
Product Code
85813-003
11-Digit Billing Format
85813000301
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ammonia Inhalants
Non-Proprietary Name
Ammonia
Substance Name
Ammonia
Dosage Form
Inhalant - A special class of inhalations consisting of a drug or combination of drugs, that by virtue of their high vapor pressure can be carried by an air current into the nasal passage where they exert their effect; the container from which the inhalant generally is administered is known as an inhaler.
Administration Route
Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
Active Ingredient(s)
AMMONIA 15 g/100mL
Usage Information
This product is used to treat or prevent fainting. It works by increasing the body's urge to breathe.

Regulatory & Marketing

Labeler Name
Direct Outlet Supplier Llc
Product Type
Human Otc Drug
FDA Application #
M011
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
11-27-2025
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 85813-003-01 identifies a specific commercial package of 50 ampule in 1 box / .3 ml in 1 ampule of Ammonia Inhalants, a human over the counter drug labeled by Direct Outlet Supplier Llc. This inhalant is formulated for respiratory (inhalation) use and contains ammonia 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 Direct Outlet Supplier Llc on November 27, 2025. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This product is used to treat or prevent fainting. It works by increasing the body's urge to breathe.

How is this Direct Outlet Supplier Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 85813000301. 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)
85813-003-01
11-Digit CMS (5-4-2)
85813-0003-01

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