Primatene Mist Aerosol
NDC Package 17270-5530-0

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

Package Information

Primatene Mist (epinephrine inhalation) aerosols is a medication used in emergencies to treat very serious allergic reactions to insect stings/bites, foods, drugs, or other substances. This formulation utilizes a aerosol delivery system. Marketed by Armstrong Pharmaceuticals, Inc., this product is identified by NDC 17270-5530 and is authorized under FDA application NDA205920.

Identification & Billing

NDC Package Code
17270-5530-0
Package Description
1 INHALER in 1 CARTON / 160 AEROSOL in 1 INHALER
Product Code
17270-5530
11-Digit Billing Format
17270553000
RxNorm Crosswalk
  • RxCUI: 2109083 - EPINEPHrine 0.125 MG/ACTUAT in 160 ACTUAT Metered Dose Inhaler
  • RxCUI: 2109083 - 160 ACTUAT epinephrine 0.125 MG/ACTUAT Metered Dose Inhaler
  • RxCUI: 2109083 - epinephrine 0.125 MG/ACTUAT per 160 ACTUAT Metered Dose Inhaler
  • RxCUI: 2109088 - Primatene MIST 0.125 MG/ACTUAT in 160 ACTUAT Metered Dose Inhaler
  • RxCUI: 2109088 - 160 ACTUAT epinephrine 0.125 MG/ACTUAT Metered Dose Inhaler [Primatene Mist Inhaler]

Clinical Specifications

Proprietary Name
Primatene Mist
Non-Proprietary Name
Epinephrine Inhalation
Substance Name
Epinephrine
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).
Administration Route
Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
Active Ingredient(s)
EPINEPHRINE 125 ug/1
Pharmacologic Class
Usage Information
This medication is used in emergencies to treat very serious allergic reactions to insect stings/bites, foods, drugs, or other substances. Epinephrine acts quickly to improve breathing, stimulate the heart, raise a dropping blood pressure, reverse hives, and reduce swelling of the face, lips, and throat.

Regulatory & Marketing

Labeler Name
Armstrong Pharmaceuticals, Inc.
Product Type
Human Otc Drug
FDA Application #
NDA205920
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-14-2018
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 17270-5530-0 identifies a specific commercial package of 1 inhaler in 1 carton / 160 aerosol in 1 inhaler of Primatene Mist, a human over the counter drug labeled by Armstrong Pharmaceuticals, Inc.. This aerosol is formulated for respiratory (inhalation) use and contains epinephrine 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 Armstrong Pharmaceuticals, Inc. on December 14, 2018. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used in emergencies to treat very serious allergic reactions to insect stings/bites, foods, drugs, or other substances. Epinephrine acts quickly to improve breathing, stimulate the heart, raise a dropping blood pressure, reverse hives, and reduce swelling of the face, lips, and throat.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 17270553000. 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)
17270-5530-0
11-Digit CMS (5-4-2)
17270-5530-00

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