Qnasl Aerosol, Metered
NDC 59310-406
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
Qnasl (beclomethasone dipropionate) is a NDA-approved product labeled by Teva Respiratory, Llc. This medication is used to treat seasonal and year-round allergy symptoms such as stuffy/runny nose, itching, and sneezing. It is supplied as a aerosol, metered for nasal administration. This product entry covers the primary NDC 59310-406 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
59310-406
Proprietary Name:
Qnasl
Non-Proprietary Name: [1]
Beclomethasone Dipropionate
Substance Name: [2]
Beclomethasone Dipropionate
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]
Nasal - Administration to the nose; administered by way of the nose.
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
59310
Product Label ID:
FDA Application Number: [6]
NDA202813
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Marketing Timeline
Start Marketing Date: [9]
01-02-2019
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
Code Structure Chart
Product Details
What is NDC 59310-406?
The NDC code 59310-406 is assigned by the FDA to the product Qnasl. It is commonly known by its generic name, beclomethasone dipropionate. This pharmaceutical product is labeled by Teva Respiratory, Llc and is currently categorized as listed product. The medication is a aerosol, metered administered via nasal route. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 59310-406-06, 59310-406-08. 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 medication is used to treat seasonal and year-round allergy symptoms such as stuffy/runny nose, itching, and sneezing. It may also reduce other symptoms of seasonal allergies such as red, itchy, and watery eyes. This medication belongs to a class of drugs known as corticosteroids. It works by reducing swelling (inflammation) in the nasal passages.
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.
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- BECLOMETHASONE DIPROPIONATE (UNII: 5B307S63B2)
- BECLOMETHASONE (UNII: KGZ1SLC28Z) (Active Moiety)
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:
- NORFLURANE (UNII: DH9E53K1Y8)
- ALCOHOL (UNII: 3K9958V90M)
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: 1797900 - beclomethasone dipropionate 40 MCG/ACTUAT Metered Dose Nasal Spray
- RxCUI: 1797900 - beclomethasone dipropionate 0.04 MG/ACTUAT Metered Dose Nasal Spray
- RxCUI: 1797902 - Qnasl 40 MCG/ACTUAT Metered Dose Nasal Spray
- RxCUI: 1797902 - beclomethasone dipropionate 0.04 MG/ACTUAT Metered Dose Nasal Spray [Qnasl]
- RxCUI: 1797902 - Qnasl 0.04 MG/ACTUAT Metered Dose Nasal Spray
Which are the Pharmacologic Classes of this product?
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.
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Patient Education
Beclomethasone Nasal Spray
Beclomethasone nasal spray is used to relieve symptoms of sneezing, runny, stuffy, or itchy nose (rhinitis) caused by hay fever, other allergies, or vasomotor (nonallergic) rhinitis. It is also used to prevent nasal polyps (swelling of the lining of the nose) after nasal polyp removal surgery. Beclomethasone nasal spray should not be used to treat symptoms (e.g., sneezing, stuffy, runny, itchy nose) caused by the common cold. Beclomethasone nasal spray is in a class of medications called corticosteroids. It works by blocking the release of certain natural substances that cause allergy symptoms.
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* 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".
