Prime Asthma Relief
NDC 15343-104

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 15343-104?
  5. Prime Asthma Relief Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

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

Prime Asthma Relief is a OTC MONOGRAPH FINAL-approved product labeled by Drnaturalhealing. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a white product. This product entry covers the primary NDC 15343-104 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
15343-104
Proprietary Name:
Prime Asthma Relief
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Drnaturalhealing
Labeler Code:
15343
Product Label ID:
6d5af590-59f6-4f34-95ff-226a2996f985
FDA Application Number: [6]
part341
Marketing Category: [8]
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.

Marketing Timeline

Start Marketing Date: [9]
08-21-2014
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I

Product Characteristics

Color(s):
WHITE (C48325)
Shape:
CAPSULE (C48336)
Size(s):
3 MM
Score:
1

Code Structure Chart

Product Details

What is NDC 15343-104?

The NDC code 15343-104 is assigned by the FDA to the product Prime Asthma Relief. This pharmaceutical product is labeled by Drnaturalhealing and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 15343-104-20. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

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.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for this product?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

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Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".