NDC 54288-123 Epinephrine Chloride Solution

Epinephrine Nasal Solution

NDC Product Code 54288-123

NDC 54288-123-01

Package Description: 10 mL in 1 BOX

NDC Product Information

Epinephrine Chloride Solution with NDC 54288-123 is a a human prescription drug product labeled by Bpi Labs, Llc. The generic name of Epinephrine Chloride Solution is epinephrine nasal solution. The product's dosage form is solution and is administered via nasal form.

Labeler Name: Bpi Labs, Llc

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Epinephrine Chloride Solution Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • EPINEPHRINE HYDROCHLORIDE 1 mg/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
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.

  • ISOTONIC SODIUM CHLORIDE SOLUTION (UNII: VR5Y7PDT5W)
  • SODIUM METABISULFITE (UNII: 4VON5FNS3C)
  • CHLOROBUTANOL (UNII: HM4YQM8WRC)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Nasal - Administration to the nose; administered by way of the nose.
  • Nasal - Administration to the nose; administered by way of the nose.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Adrenergic alpha-Agonists - [MoA] (Mechanism of Action)
  • Adrenergic beta-Agonists - [MoA] (Mechanism of Action)
  • alpha-Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
  • beta-Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
  • Catecholamine - [EPC] (Established Pharmacologic Class)
  • Catecholamines - [CS]

Product Labeler Information

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

Labeler Name: Bpi Labs, Llc
Labeler Code: 54288
Marketing Category: UNAPPROVED DRUG OTHER - 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.

Start Marketing Date: 09-30-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 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.

Exclude Flag: N 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Epinephrine Chloride Solution Product Label Images

Epinephrine Chloride Solution Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Warnings And Precautions

Caution: Administer with caution to elderly people. Do not use if high blood pressure, heart disease, diabetes, or thyroid disease is present unless directed by a physician. If prompt relief is not obtained, consult a physician. Administer to pediatric patients under six years of age only on the advice of a physician.

Indcation And Use

For use as a nasal decongestant.Apply locally as drops or spray, or with a sterile swab, as required.Instructions for diluting To make Epinephrine Chloride SolutionEpinephrine Chloride Solution 1 mg/mLIsotonic Salt Solution 0.5 mg/mL 1 mL 1 mL 0.2 mg/mL 1 mL 4 mL 0.1 mg/mL 1 mL 9 mL

Dosage And Administration

Each mL contains 1 mg Epinephrine as the hydrochloride, dissolved in isotonic sodium chloride solution with 0.5% chlorobutanol (chloroform derivative) as a preservative and not more than 0.05% sodium metabisulfite as an antioxidant.EPINEPHrine nasal solution, USP must not be brought into contact with oxidizing agents.The solution is also quickly decomposed by iron salts and alkalies.

Adverse Reactions Sections

To report SUSPECTED ADVERSE REACTIONS, contact BPI Labs, LLC at 1-727-471-0850 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

How Supplied Section

EPINEPhrine Chloride Solution 10mg/10ml (1mg/1ml) in 10ml vial.NDC 54288-123-01This product is sterile until opened.Keep this and all drugs out of the reach of children.Store between 20° to 25°C (68° to 77°F). (See USP Controlled Room Temperature.) Do not refrigerate or freeze, Protect from light.Do not use if cap seal is broken or missing.Manufactured by:BPI Labs, LLCLargo, FL 33773.Rev: 08/2020LI123C-01R-2005

Principal Display Pannel

Manufactured by:BPI Labs, LLCLargo, FL 33773.Rev: 08/2020LI123C-01R-2005

* Please review the disclaimer below.