NDC 60687-395 Albuterol Sulfate
Solution Respiratory (inhalation)

Product Information

Albuterol Sulfate is a human prescription drug product labeled by American Health Packaging. The product's dosage form is solution and is administered via respiratory (inhalation) form.

Product Code60687-395
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.
Albuterol Sulfate
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.
Albuterol Sulfate
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 Prescription 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.
American Health Packaging
Labeler Code60687
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.
ANDA077839
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.
ANDA - A product marketed under an approved Abbreviated New Drug Application.
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.
12-26-2018
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 Albuterol Sulfate?


Product Packages

NDC 60687-395-83

Package Description: 30 POUCH in 1 CARTON > 1 AMPULE in 1 POUCH (60687-395-79) > 3 mL in 1 AMPULE

Price per Unit: $0.04361 per ML

Product Details

What are Albuterol Sulfate 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.
  • ALBUTEROL SULFATE 2.5 mg/3mL - A short-acting beta-2 adrenergic agonist that is primarily used as a bronchodilator agent to treat ASTHMA. Albuterol is prepared as a racemic mixture of R(-) and S(+) stereoisomers. The stereospecific preparation of R(-) isomer of albuterol is referred to as levalbuterol.

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:

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.
  • WATER (UNII: 059QF0KO0R)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SULFURIC ACID (UNII: O40UQP6WCF)

Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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Patient Education

Albuterol Oral Inhalation

Albuterol Oral Inhalation is pronounced as (al byoo' ter ole)

Why is albuterol oral inhalation medication prescribed?
Albuterol is used to prevent and treat difficulty breathing, wheezing, shortness of breath, coughing, and chest tightness caused by lung diseases such as asthma and chron...
[Read More]

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Albuterol Sulfate Labeling and Warnings

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.

Table of Contents



Clinical Pharmacology



The prime action of beta-adrenergic drugs is to stimulate adenyl cyclase, the enzyme which catalyzes the formation of cyclic-3',5'-adenosine monophosphate (cyclic AMP) from adenosine triphosphate (ATP). The cyclic AMP thus formed mediates the cellular responses. In vitro studies and in vivo pharmacologic studies have demonstrated that albuterol has a preferential effect on beta 2-adrenergic receptors compared with isoproterenol. While it is recognized that beta 2-adrenergic receptors are the predominant receptors in bronchial smooth muscle, 10% to 50% of the beta-receptors in the human heart may be beta 2-receptors. The precise function of these receptors, however, is not yet established. Albuterol has been shown in most controlled clinical trials to have more effect on the respiratory tract in the form of bronchial smooth muscle relaxation than isoproterenol at comparable doses while producing fewer cardiovascular effects. Controlled clinical studies and other clinical experience have shown that inhaled albuterol, like other beta-adrenergic agonist drugs, can produce a significant cardiovascular effect in some patients, as measured by pulse rate, blood pressure, symptoms, and/or electrocardiographic changes.

Albuterol is longer acting than isoproterenol in most patients by any route of administration because it is not a substrate for the cellular uptake processes for catecholamines nor for catechol-O-methyl transferase.

Studies in asthmatic patients have shown that less than 20% of a single albuterol dose was absorbed following IPPB (intermittent positive-pressure breathing) or nebulizer administration; the remaining amount was recovered from the nebulizer and apparatus and expired air. Most of the absorbed dose was recovered in the urine 24 hours after drug administration. Following a 3 mg dose of nebulized albuterol, the maximum albuterol plasma level at 0.5 hour was 2.1 ng/mL (range 1.4 to 3.2 ng/mL). There was a significant dose-related response in FEV 1 (forced expiratory volume in one second) and peak flow rate.

It has been demonstrated that following oral administration of 4 mg albuterol, the elimination half-life was five to six hours.

Animal studies show that albuterol does not pass the blood-brain barrier. Recent studies in laboratory animals (minipigs, rodents, and dogs) recorded the occurrence of cardiac arrhythmias and sudden death (with histologic evidence of myocardial necrosis) when beta-agonists and methylxanthines were administered concurrently. The significance of these findings when applied to humans is currently unknown.

In controlled clinical trials, most patients exhibited an onset of improvement in pulmonary function within 5 minutes as determined by FEV 1. FEV 1 measurements also showed that the maximum average improvement in pulmonary function usually occurred at approximately 1 hour following inhalation of 2.5 mg of albuterol by compressor-nebulizer, and remained close to peak for 2 hours. Clinically significant improvement in pulmonary function (defined as maintenance of a 15% or more increase in FEV 1 over baseline values) continued for 3 to 4 hours in most patients and in some patients continued up to 6 hours.

In repetitive dose studies, continued effectiveness was demonstrated throughout the three-month period of treatment in some patients.

Published reports of trials in asthmatic children aged 3 years or older have demonstrated significant improvement in either FEV 1 or PEFR within 2 to 20 minutes following single dose of albuterol inhalation solution. An increase of 15% or more in baseline FEV 1 has been observed in children aged 5 to 11 years up to 6 hours after treatment with doses of 0.10 mg/kg or higher of albuterol inhalation solution. Single doses of 3, 4, or 10 mg resulted in improvement in baseline PEFR that was comparable to extent and duration to a 2 mg dose, but doses above 3 mg were associated with heart rate increases of more than 10%.


Patient's Instructions For Use



Albuterol Sulfate Inhalation Solution 0.083%

(Potency expressed as albuterol, equivalent to 3 mg albuterol sulfate).


Note: This is a unit-dose vial. No dilution is required.

Read complete instructions carefully before using.

  • Remove the vial from the foil pouch.
  • Twist the cap completely off the vial and squeeze the contents into the nebulizer reservoir (Figure 1).
  • Connect the nebulizer reservoir to the mouthpiece or face mask (Figure 2).
  • Connect the nebulizer to the compressor.
  • Sit in a comfortable, upright position; place the mouthpiece in your mouth (Figure 3) (or put on the face mask); and turn on the compressor.
  • Breathe as calmly, deeply and evenly as possible until no more mist is formed in the nebulizer chamber (about 5 to 15 minutes). At this point, the treatment is finished.
  • Clean the nebulizer (see manufacturer's instructions).
  • Note: Use only as directed by your physician. More frequent administration or higher doses are not recommended.

    Store Albuterol Sulfate Inhalation Solution 0.083% between 2° and 25° C (36° and 77° F). Store in pouch until time of use.

    ADDITIONAL INSTRUCTIONS: ______________________________________________________________________________________

    To report SUSPECTED ADVERSE REACTIONS, contact American Health Packaging at 1-800-707-4621 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

    Manufactured by:
    The Ritedose Corporation
    Columbia, SC 29203

    Distributed by:
    American Health Packaging
    Columbus, OH 43217

    RPIN0101
    September 2018


Package/Label Display Panel – Carton – 2.5 Mg Per 3 Ml



NDC 60687- 395-83

Albuterol Sulfate
Inhalation Solution, 0.083%*

2.5 mg/3 mL*
*Potency expressed as albuterol, equivalent to 3 mg albuterol sulfate.

30 x 3 mL Sterile Unit-Dose Vials,
each in a foil pouch.

Rx Only
FOR ORAL INHALATION ONLY

Each mL contains 1 mg albuterol sulfate, equivalent to 0.83 mg albuterol in an aqueous solution containing
sodium chloride and sulfuric acid to adjust pH between 3 and 5. Contains no preservatives.

Equivalent to 0.5 mL Albuterol Sulfate 0.5%* diluted to 3 mL with normal saline.

Usual Dosage: See package insert.
Please consult your physician before use. Do not exceed recommended dosage.

Protect from light. Store between 2° and 25°C (36° and 77°F). Discard if solution becomes discolored.
(Note: Albuterol Sulfate Inhalation Solution is a clear, colorless to light yellow solution.)

Rx Only

Attention Pharmacist: Detach "Patient's Instructions For Use"
from package insert and dispense with solution.

Manufactured by: The Ritedose Corporation, Columbia, SC 29203
Distributed by: American Health Packaging, Columbus, OH 43217


Package/Label Display Panel – Pouch – 2.5 Mg Per 3 Ml



NDC 60687-395-79

Albuterol Sulfate
Inhalation Solution,
0.083%*

2.5 mg/3 mL*

* Potency expressed as albuterol,
equivalent to 3 mg albuterol sulfate.

FOR ORAL INHALATION ONLY

Equivalent to 0.5 mL albuterol
sulfate 0.5%* diluted to 3 mL with
normal saline.

Each mL contains 1 mg albuterol
sulfate, equivalent to 0.83 mg
albuterol, in an aqueous solution
containing sodium chloride and
sulfuric acid to adjust pH between 3
and 5. Contains no preservatives.

Please consult your physician before
use. Do not exceed recommended
dosage.

Usual Dosage: See package insert.

Store between 2° and 25°C (36° and
77°F). Protect from light.

Discard if solution becomes
discolored. (Note: Albuterol Sulfate
Inhalation Solution is a clear, colorless
to light yellow solution.)

Attention Pharmacist: Detach
"Patient's Instructions For Use"
from package insert and dispense with
solution.

Rx Only

STERILE

One 3 mL Unit-Dose Vial

Manufactured by:
The Ritedose
Corporation
Columbia, SC 29203

Distributed by:
American Health
Packaging
Columbus, OH 43217

RPFP0222


* Please review the disclaimer below.