Amyl Nitrite Inhalant
NDC Package 46414-2222-8

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

Package Information

Amyl Nitrite inhalants is amyl nitrite is indicated for the rapid relief of angina pectoris.  Its effect appears within 30 seconds and lasts for approximately 3 to 5 minutes. This formulation utilizes a inhalant delivery system. Marketed by James Alexander Corporation, this product is identified by NDC 46414-2222.

Identification & Billing

NDC Package Code
46414-2222-8
Package Description
144 AMPULE in 1 CARTON / .3 mL in 1 AMPULE (46414-2222-1)
Product Code
46414-2222
11-Digit Billing Format
46414222208
RxNorm Crosswalk
RxCUI: 577307 - amyl nitrite 0.3 ML Nasal Inhalant

Clinical Specifications

Proprietary Name
Amyl Nitrite
Non-Proprietary Name
Amyl Nitrite
Substance Name
Amyl Nitrite
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)
AMYL NITRITE .3 g/.3mL
Usage Information
Amyl nitrite is indicated for the rapid relief of angina pectoris.  Its effect appears within 30 seconds and lasts for approximately 3 to 5 minutes.

Regulatory & Marketing

Labeler Name
James Alexander Corporation
Product Type
Human Prescription Drug
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
02-07-1979
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 46414-2222-8 identifies a specific commercial package of 144 ampule in 1 carton / .3 ml in 1 ampule (46414-2222-1) of Amyl Nitrite, a human prescription drug labeled by James Alexander Corporation. This inhalant is formulated for respiratory (inhalation) use and contains amyl nitrite 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 James Alexander Corporation on February 07, 1979. The current certification is valid through December 31, 2026.

How is this James Alexander Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 46414222208. 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 (5-4-1)
46414-2222-8
11-Digit CMS (5-4-2)
46414-2222-08

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