Prime Asthma Relief
NDC Package 15343-105-40

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Prime Asthma Relief is do not use more than directedadults and children 4 years of age and over: 1 capsule is for one inhalation at one timeinhalation not more often than every 3 hoursdo not use more than 12 inhalations in 24 hoursthe use of this product by children should be supervised by an adultchildren under 4 years of age: ask a doctor1) The active ingredient in a dry powder is 0.22 mg per capsule (the concentration is 1% epinephrine in the total weight of the dry powder)2) For use in a dry powder inhaler for holding the No. Marketed by Drnaturalhealing, this product is identified by NDC 15343-105 and is authorized under FDA application part341.

Identification & Billing

NDC Package Code
15343-105-40
Package Description
1 BLISTER PACK in 1 CARTON / 40 CAPSULE in 1 BLISTER PACK
Product Code
15343-105
11-Digit Billing Format
15343010540
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Prime Asthma Relief
Dosage Form
-
Usage Information
Do not use more than directedadults and children 4 years of age and over: 1 capsule is for one inhalation at one timeinhalation not more often than every 3 hoursdo not use more than 12 inhalations in 24 hoursthe use of this product by children should be supervised by an adultchildren under 4 years of age: ask a doctor1) The active ingredient in a dry powder is 0.22 mg per capsule (the concentration is 1% epinephrine in the total weight of the dry powder)2) For use in a dry powder inhaler for holding the No. 3 capsule. 3) Should orally inhale at least two times after the capsule is pierced to make sure all dry powder is inhaled into the lung4) Instructions for Inhalation: A. Inhaler parts: B. Instructions for using the dry powder inhaler: Wash and dry your hands completely before touching the inhaler and capsule. (1) Remove the cap. (2) Hold the inhaler at base and turn the mouthpiece in direction of the arrow. (3) Obtain 1 capsule from the blister package just prior to use. (4) Open inhaler by turning mouthpiece as indicated. Load 1 capsule in the capsule-chamber of the inhaler. Do not put the capsule directly into the top of the mouthpiece. Twist the mouthpiece to the closed position. (5) Hold the inhaler upright, push/click two blue buttons inwards all the way. Let go of the blue buttons. Do not press the blue buttons more than 1 time. The chances of the capsule breaking into pieces will be increased if the capsule is accidentally pierced more than once. (6) With the inhaler away from your mouth, prepare by breathing out (exhaling) all the way. Do not blow or exhale into the mouthpiece. (7) Hold the inhaler horizontally. Place your mouth over the mouthpiece and close your lips tightly around it. Inhale quickly and deeply. (8) Hold your breath for count of ten, or as long as is comfortable. Breathe out gently. You will need to inhale at least twice from one capsule in order to get the full dose. (9) After the dose, open the mouthpiece, remove the used capsule, and take a look at the used capsule. It should be pierced and empty. If so, dispose of it properly. If the capsule does not look pierced, put the capsule back into the device capsule-chamber, repeat steps 7, 8 and 9. (10) Cover the mouthpiece and dust cap for storage. (11) After your Inhalation, throw away the empty capsule properly as it is bio-degradable. Do not store the capsule in the inhaler. Put the mouthpiece back to your inhaler device and twist the mouthpiece in a clockwise direction until it is tight. Do not over-tighten.

Regulatory & Marketing

Labeler Name
Drnaturalhealing
FDA Application #
part341
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
08-21-2014
Listing Expiration
12-31-2017
Exclude Flag
I
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 15343-105-40 identifies a specific commercial package of 1 blister pack in 1 carton / 40 capsule in 1 blister pack of Prime Asthma Relief, labeled by Drnaturalhealing. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Drnaturalhealing on August 21, 2014. The current certification is valid through December 31, 2017.

How is this Drnaturalhealing product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 15343010540. 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)
15343-105-40
11-Digit CMS (5-4-2)
15343-0105-40

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