NDC 0591-3467 Albuterol Sulfate
Solution Intrabronchial

Product Information

Albuterol Sulfate is a human prescription drug product labeled by Actavis Pharma, Inc.. The product's dosage form is solution and is administered via intrabronchial form.

Product Code0591-3467
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.
  • Intrabronchial - Administration within a bronchus.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Actavis Pharma, Inc.
Labeler Code0591
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.
ANDA077772
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.
09-25-2007
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.
12-31-2022
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 0591-3467-53

Package Description: 5 POUCH in 1 CARTON > 5 VIAL in 1 POUCH > 3 mL in 1 VIAL

Price per Unit: $0.13610 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 .63 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:
  • RxCUI: 351136 - albuterol sulfate 0.042 % (1.25 MG/3 ML) Inhalation Solution
  • RxCUI: 351136 - albuterol 0.417 MG/ML Inhalation Solution
  • RxCUI: 351136 - albuterol 0.042 % (1.25 MG/3 ML) Inhalation Solution
  • RxCUI: 351136 - albuterol 1.25 MG (albuterol sulfate 1.5 MG) per 3 ML Inhalation Solution
  • RxCUI: 351137 - albuterol sulfate 0.021 % (0.63 MG/3 ML) Inhalation Solution

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

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.

* Please review the disclaimer below.

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]

* Please review the disclaimer below.

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



* Please review the disclaimer below.