1. Home
  2. Labeler Index
  3. Epiphaniq Llc
  4. NDC Product Code: 79813-203 Epiphaniq Sterile For Oral Inhalation Only

NDC 79813-203 Epiphaniq Sterile For Oral Inhalation Only

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 79813-203?
  4. Epiphaniq Sterile For Oral Inhalation Only Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
79813-203
Proprietary Name:
Epiphaniq Sterile For Oral Inhalation Only
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Epiphaniq Llc
Labeler Code:
79813
Product Label ID:
8bbf8d49-3274-4d59-a14e-d23e1eff073b
Start Marketing Date: [9]
07-23-2020
Listing Expiration Date: [11]
12-31-2022
Exclude Flag: [12]
I
Code Navigator:

Code Structure Chart

Product Details

What is NDC 79813-203?

The NDC code 79813-203 is assigned by the FDA to the product Epiphaniq Sterile For Oral Inhalation Only which is product labeled by Epiphaniq Llc. The product's dosage form is . The product is distributed in a single package with assigned NDC code 79813-203-51 1 bottle in 1 carton / 60 ml in 1 bottle (79813-203-11). This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Epiphaniq Sterile For Oral Inhalation Only?

Note: The EpiphaniQ inhalation solution contained in the 60 ml bottle does not require dilution. The solution should be poured directly into the nebulizer as per the instructions below.Read complete instructions carefully before using EpiphaniQ.Draw 5ml of EpiphaniQ solution into the specially marked dropper that comes with each bottle.Squeeze the solution into the nebulizer reservoir through the appropriate openingGently swirl the nebulizer to mix the contents. Connect the nebulizer to the mouthpiece or facemaskConnect the nebulizer to the compressorSit in a comfortable upright position. Place the mouthpiece in your mouth or put on the face mask. Turn the compressor on.Breathe as calmly, deeply and evenly as possible until no more mist is formed in the nebulizer chamber (about 5 – 15 minutes). At this point, the treatment is finished.Clean the nebulizer (see manufacturer’s instructions)Note: Can be used two – three times per day. More frequent administration or higher doses are not recommended.

Which are Epiphaniq Sterile For Oral Inhalation Only UNII Codes?

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

Which are Epiphaniq Sterile For Oral Inhalation Only Inactive Ingredients 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:

* Please review the disclaimer below.

Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] 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.

[12] 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".