NDC 76204-010 Albuterol Sulfate Inhalation Solution
Albuterol Sulfate Solution Respiratory (inhalation)

Product Information

What is NDC 76204-010?

The NDC code 76204-010 is assigned by the FDA to the product Albuterol Sulfate Inhalation Solution which is a human prescription drug product labeled by Ritedose Pharmaceuticals, Llc. The generic name of Albuterol Sulfate Inhalation Solution is albuterol sulfate. The product's dosage form is solution and is administered via respiratory (inhalation) form. The product is distributed in 2 packages with assigned NDC codes 76204-010-01 30 pouch in 1 carton / 1 vial in 1 pouch (76204-010-11) / 3 ml in 1 vial, 76204-010-55 25 pouch in 1 carton / 5 vial in 1 pouch (76204-010-05) / 3 ml in 1 vial. 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 Code76204-010
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 Inhalation Solution
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.
Ritedose Pharmaceuticals, Llc
Labeler Code76204
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.
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.
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.
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".
NDC Code Structure

What are the uses for Albuterol Sulfate Inhalation Solution?

Product Packages

NDC Code 76204-010-01

Package Description: 30 POUCH in 1 CARTON / 1 VIAL in 1 POUCH (76204-010-11) / 3 mL in 1 VIAL

Price per Unit: $0.22993 per ML

NDC Code 76204-010-55

Package Description: 25 POUCH in 1 CARTON / 5 VIAL in 1 POUCH (76204-010-05) / 3 mL in 1 VIAL

Price per Unit: $0.18252 per ML

Product Details

What are Albuterol Sulfate Inhalation Solution 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.

Albuterol Sulfate Inhalation Solution 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:
  • 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

Albuterol Sulfate Inhalation Solution 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.

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.

Albuterol Sulfate Inhalation Solution 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

* Please review the disclaimer below.