Acetylcysteine Solution
NDC 0409-3308

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 0409-3308?
  4. Acetylcysteine Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Pharmacologic Classes
  10. Patient Education

Product Information

Acetylcysteine is a ANDA-approved product labeled by Hospira, Inc.. When inhaled by mouth, acetylcysteine is used to help thin and loosen mucus in the airways due to certain lung diseases (such as emphysema, bronchitis, cystic fibrosis, pneumonia). It is supplied as a solution for oral; respiratory (inhalation) administration. This product entry covers the primary NDC 0409-3308 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
0409-3308
Proprietary Name:
Acetylcysteine
Non-Proprietary Name: [1]
Acetylcysteine
Substance Name: [2]
Acetylcysteine
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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Clinical Specifications

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.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
  • Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.

Labeler & Regulatory Data

Labeler Name: [5]
Hospira, Inc.
Labeler Code:
0409
Product Label ID:
5558a5f5-e821-473b-7d8a-5d33d09f0586
HCPCS Code:
J7608 - Acetylcysteine non-comp unit
FDA Application Number: [6]
ANDA074037
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
06-01-2005
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 0409-3308?

The NDC code 0409-3308 is assigned by the FDA to the product Acetylcysteine. This pharmaceutical product is labeled by Hospira, Inc. and is currently categorized as listed product. The medication is a solution administered via oral; respiratory (inhalation) route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 0409-3308-03. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

When inhaled by mouth, acetylcysteine is used to help thin and loosen mucus in the airways due to certain lung diseases (such as emphysema, bronchitis, cystic fibrosis, pneumonia). This effect helps you to clear the mucus from your lungs so that you can breathe easier. When taken by mouth, acetylcysteine is used to prevent liver damage from acetaminophen overdose.

What are Active Ingredients of this product?

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.
  • ACETYLCYSTEINE 200 mg/mL - The N-acetyl derivative of CYSTEINE. It is used as a mucolytic agent to reduce the viscosity of mucous secretions. It has also been shown to have antiviral effects in patients with HIV due to inhibition of viral stimulation by reactive oxygen intermediates.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated 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. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for this product?

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:

Which are the Pharmacologic Classes of this product?

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Patient Education

Acetylcysteine Oral Inhalation


Acetylcysteine inhalation is used along with other treatments to relieve chest congestion due to thick or abnormal mucous secretions in people with lung conditions including asthma, emphysema, bronchitis and cystic fibrosis (an inborn disease that causes problems with breathing, digestion, and reproduction). Acetylcysteine is in a class of medications called mucolytic agents. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.
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Product & Regulatory Definitions
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.
What is the Substance Name? 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.
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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".