Bevespi Aerosphere Aerosol, Metered
NDC 0310-4600

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 0310-4600?
  4. Bevespi Aerosphere 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

Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) is a NDA-approved product labeled by Astrazeneca Pharmaceuticals Lp. This product is used to control and prevent symptoms (such as wheezing and shortness of breath) caused by ongoing lung disease (chronic obstructive pulmonary disease-COPD, which includes chronic bronchitis and emphysema). It is supplied as a aerosol, metered for respiratory (inhalation) administration. This product entry covers the primary NDC 0310-4600 and 3 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
0310-4600
Proprietary Name:
Bevespi Aerosphere
Non-Proprietary Name: [1]
Glycopyrrolate And Formoterol Fumarate
Substance Name: [2]
Formoterol Fumarate; Glycopyrrolate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Aerosol, Metered - A pressurized dosage form consisting of metered dose valves which allow for the delivery of a uniform quantity of spray upon each activation.
Administration Route(s): [4]
Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.

Labeler & Regulatory Data

Labeler Name: [5]
Astrazeneca Pharmaceuticals Lp
Labeler Code:
0310
Product Label ID:
ae02436e-9528-490e-a844-0c0f6f2843f9
FDA Application Number: [6]
NDA208294
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
10-03-2016
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 0310-4600?

The NDC code 0310-4600 is assigned by the FDA to the product Bevespi Aerosphere. It is commonly known by its generic name, glycopyrrolate and formoterol fumarate. This pharmaceutical product is labeled by Astrazeneca Pharmaceuticals Lp and is currently categorized as listed product. The medication is a aerosol, metered administered via respiratory (inhalation) route. In terms of distribution, this product is available in 3 different package configurations. The associated package NDC(s) include: 0310-4600-12, 0310-4600-28, 0310-4600-39. 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?

This product is used to control and prevent symptoms (such as wheezing and shortness of breath) caused by ongoing lung disease (chronic obstructive pulmonary disease-COPD, which includes chronic bronchitis and emphysema). Controlling symptoms of breathing problems helps you maintain your normal activities and decreases time lost from work or school. This inhaler contains 2 medications: glycopyrrolate and formoterol. Both drugs work by relaxing the muscles around the airways so that they open up and you can breathe more easily. Glycopyrrolate belongs to a class of drugs known as anticholinergics. Formoterol belongs to the class of drugs known as long-acting beta agonists (LABAs). Both drugs are also known as bronchodilators. This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden breathing problems. If sudden shortness of breath occurs, use your quick-relief inhaler as prescribed. Glycopyrrolate/formoterol is not approved to treat asthma. People with asthma using long-acting inhaled beta agonists (such as formoterol) without also using an inhaled corticosteroid may have an increased risk of serious (sometimes fatal) breathing problems.

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.
  • FORMOTEROL FUMARATE 4.8 ug/1 - An ADRENERGIC BETA-2 RECEPTOR AGONIST with a prolonged duration of action. It is used to manage ASTHMA and in the treatment of CHRONIC OBSTRUCTIVE PULMONARY DISEASE.
  • GLYCOPYRROLATE 9 ug/1 - A muscarinic antagonist used as an antispasmodic, in some disorders of the gastrointestinal tract, and to reduce salivation with some anesthetics.

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:
  • RxCUI: 1790639 - glycopyrrolate/formoterol fumarate 9/4.8 MCG/INHAL Metered Dose Inhaler, 120 Actuations
  • RxCUI: 1790639 - 120 ACTUAT formoterol fumarate 0.0048 MG/ACTUAT / glycopyrrolate 0.009 MG/ACTUAT Metered Dose Inhaler
  • RxCUI: 1790639 - formoterol fumarate 0.0048 MG/ACTUAT / glycopyrrolate 0.009 MG/ACTUAT 120 ACTUAT Metered Dose Inhaler
  • RxCUI: 1790644 - BEVESPI Aerosphere 9/4.8 MCG/INHAL Metered Dose Inhaler, 120 Actuations
  • RxCUI: 1790644 - 120 ACTUAT formoterol fumarate 0.0048 MG/ACTUAT / glycopyrrolate 0.009 MG/ACTUAT Metered Dose Inhaler [Bevespi]

Which are the Pharmacologic Classes of this product?

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Patient Education

Formoterol Oral Inhalation


Formoterol oral inhalation is used to control wheezing, shortness of breath, and chest tightness caused by chronic obstructive pulmonary disease (COPD; a group of lung diseases that includes chronic bronchitis and emphysema). Formoterol is in a class of medications called long-acting beta agonists (LABAs). It works by relaxing and opening air passages in the lungs, making it easier to breathe.
[Learn More]


Glycopyrrolate Oral Inhalation


Glycopyrrolate oral inhalation is used as a long term treatment to control wheezing, shortness of breath, coughing, and chest tightness in patients with chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways, that includes chronic bronchitis and emphysema). Glycopyrrolate is in a class of medications called anticholinergics. It works by relaxing the muscles around the airways in your lungs, making it easier to breathe.
[Learn More]


* Please review the full disclaimer at the bottom of this page.

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".