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  5. NDC Package Code: 0310-4600-12 Bevespi Aerosphere

NDC Package 0310-4600-12 Bevespi Aerosphere

Glycopyrrolate And Formoterol Fumarate Aerosol, Metered Respiratory (inhalation) - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
0310-4600-12
Package Description:
120 AEROSOL, METERED in 1 INHALER
Product Code:
0310-4600
Proprietary Name:
Bevespi Aerosphere
Non-Proprietary Name:
Glycopyrrolate And Formoterol Fumarate
Substance Name:
Formoterol Fumarate; Glycopyrrolate
Usage Information:
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.
11-Digit NDC Billing Format:
00310460012
NDC to RxNorm Crosswalk:
  • 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]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Astrazeneca Pharmaceuticals Lp
    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):
  • Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
    • Active Ingredient(s):
  • FORMOTEROL FUMARATE 4.8 ug/1
  • GLYCOPYRROLATE 9 ug/1
    • Pharmacologic Class(es):
  • Adrenergic beta2-Agonists - [MoA] (Mechanism of Action)
  • Anticholinergic - [EPC] (Established Pharmacologic Class)
  • Cholinergic Antagonists - [MoA] (Mechanism of Action)
  • beta2-Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    NDA208294
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    10-03-2016
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0310-4600-12?

    The NDC Packaged Code 0310-4600-12 is assigned to a package of 120 aerosol, metered in 1 inhaler of Bevespi Aerosphere, a human prescription drug labeled by Astrazeneca Pharmaceuticals Lp. The product's dosage form is aerosol, metered and is administered via respiratory (inhalation) form.

    Is NDC 0310-4600 included in the NDC Directory?

    Yes, Bevespi Aerosphere with product code 0310-4600 is active and included in the NDC Directory. The product was first marketed by Astrazeneca Pharmaceuticals Lp on October 03, 2016 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 0310-4600-12?

    The 11-digit format is 00310460012. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    4-4-20310-4600-125-4-200310-4600-12