NDC 0487-2784 Asthmanefrin
Racepinephrine Hydrochloride Solution Respiratory (inhalation)

Product Information

What is NDC 0487-2784?

The NDC code 0487-2784 is assigned by the FDA to the product Asthmanefrin which is a human over the counter drug product labeled by Nephron Pharmaceuticals Corporation. The generic name of Asthmanefrin is racepinephrine hydrochloride. The product's dosage form is solution and is administered via respiratory (inhalation) form. The product is distributed in a single package with assigned NDC code 0487-2784-01 30 pouch in 1 carton / 1 vial, single-use in 1 pouch / .5 ml in 1 vial, single-use. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code0487-2784
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Asthmanefrin
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Racepinephrine Hydrochloride
Product Type 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.
Human Otc Drug
Dosage FormSolution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Nephron Pharmaceuticals Corporation
Labeler Code0487
FDA Application Number 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.
part341
Marketing Category 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.
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
08-01-2012
Listing Expiration Date 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.
12-31-2023
Exclude Flag 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".
N
NDC Code Structure

What are the uses for Asthmanefrin?


Product Packages

NDC Code 0487-2784-01

Package Description: 30 POUCH in 1 CARTON / 1 VIAL, SINGLE-USE in 1 POUCH / .5 mL in 1 VIAL, SINGLE-USE

Price per Unit: $0.75414 per EA

Product Details

What are Asthmanefrin Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Asthmanefrin Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? 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:

Asthmanefrin 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.

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Asthmanefrin Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Other



Drug Facts

Asthma alert: Because asthma may be life threatening, see a doctor if you:

  • Are not better in 20 minutes
  • Get worse
  • Need more than 12 inhalations in 24 hours
  • Use more than 9 inhalations in 24 hours for 3 or more days a week
  • Have more than 2 asthma attacks in a week
  • These may be signs that your asthma is getting worse.

    Manufactured By:

    nephron

    pharmaceuticals

    corporation


    West Columbia, SC 29172


Active Ingredient (In Each 0.5 Ml)



Racepinephrine, USP 11.25 mg (as 13.5 mg of Racepinephrine HCl, USP).


Purpose



Bronchodilator


Uses



For temporary relief of mild symptoms of intermittent asthma:

  • Wheezing
  • Tightness of chest
  • Shortness of breath

Otc - Do Not Use



Do not use:

  • Unless a doctor said you have asthma
  • If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains a MAOI, ask a doctor or pharmacist before taking this product.
  • If product is brown in color or cloudy

Otc - Ask Doctor



Ask a doctor before use if you have:

  • Ever been hospitalized for asthma
  • Heart disease
  • High blood pressure
  • Diabetes
  • Thyroid disease
  • Seizures
  • Narrow angle glaucoma
  • A psychiatric or emotional condition
  • Trouble urinating due to an enlarged prostate gland

Otc - Ask Doctor/Pharmacist



Ask a doctor or pharmacist before use if you are:

  • Taking prescription drugs for asthma, obesity, weight control, depression, or psychiatric or emotional conditions.
  • Taking any drug that contains phenylephrine, pseudoephedrine, ephedrine, or caffeine (such as for allergy, cough-cold, or pain).

Otc - Stop Use



Stop use and ask a doctor if:

  • Your asthma is getting worse (See Asthma alert)
  • You have difficulty sleeping
  • You have a rapid heartbeat
  • You have tremors, nervousness, or seizure

Otc - When Using



When using this product:

  • Your blood pressure or heart rate may go up. This could increase your risk of heart attack or stroke, which may cause death.
  • Your risk of heart attack or stroke increases if you:
    • Have a history of high blood pressure or heart disease
    • Take this product more frequently or take more than the recommended dose.
    • Avoid foods or beverages that contain caffeine
    • Avoid dietary supplements containing ingredients reported or claimed to have a stimulant effect.

Otc - Pregnancy Or Breast Feeding



  • If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children



  • Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions



  • The ingredient is used in an aqueous solution at a concentration equivalent to 1 percent epinephrine.
  • Do not use more than directed
  • For use in a hand-held rubber bulb nebulizer:
  • Add 0.5 mL (contents of one vial) of solution to nebulizer.
  • Adults and children 4 years of age and over:
    1 to 3 inhalations not more often than every 3 hours.
    Do not use more than 12 inhalations in 24 hours.
    The use of this product by children should be supervised by an adult.
  • Children under 4 years of age: ask a doctor.

Storage And Handling



  • Protect from light. Avoid excessive heat. Protect from freezing.
  • Store between 2°C and 25°C (36°F and 77°F).
  • How Supplied: Asthmanefrin ® Racepinephrine Inhalation Solution, USP 2.25% is supplied in 0.5 mL sterile vials.
    NDC 0487-2784-01 30 vials, each vial in an individual foil pouch.

Inactive Ingredients



Ascorbic acid, citric acid, edetate disodium, water for injection.


Questions?



1-855-999-EZAN (3926)

Monday through Friday, 8:00 a.m. to 5:00 p.m. (Eastern Standard Time).


* Please review the disclaimer below.