NDC 0037-0245 Dymista

Azelastine Hydrochloride And Fluticasone Propionate Spray, Metered Nasal - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0037-0245
Proprietary Name:
Dymista
Non-Proprietary Name: [1]
Azelastine Hydrochloride And Fluticasone Propionate
Substance Name: [2]
Azelastine Hydrochloride; Fluticasone Propionate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Spray, Metered - A non-pressurized dosage form consisting of valves which allow the dispensing of a specified quantity of spray upon each activation.
Administration Route(s): [4]
  • Nasal - Administration to the nose; administered by way of the nose.
  • Labeler Name: [5]
    Meda Pharmaceuticals Inc.
    Labeler Code:
    0037
    FDA Application Number: [6]
    NDA202236
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    05-01-2012
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 0037-0245-23

    Package Description: 1 BOTTLE, SPRAY in 1 BOX / 120 SPRAY, METERED in 1 BOTTLE, SPRAY

    Price per Unit: $8.71602 per GM

    Product Details

    What is NDC 0037-0245?

    The NDC code 0037-0245 is assigned by the FDA to the product Dymista which is a human prescription drug product labeled by Meda Pharmaceuticals Inc.. The generic name of Dymista is azelastine hydrochloride and fluticasone propionate. The product's dosage form is spray, metered and is administered via nasal form. The product is distributed in a single package with assigned NDC code 0037-0245-23 1 bottle, spray in 1 box / 120 spray, metered in 1 bottle, spray. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Dymista?

    This product is used to relieve seasonal allergy symptoms of the nose such as stuffy/runny nose, itching, sneezing, and post-nasal drip. It contains 2 drugs. Azelastine is an antihistamine that works by blocking certain natural substances called histamines that are responsible for allergic symptoms. Fluticasone belongs to a class of drugs known as corticosteroids. It works by reducing swelling (inflammation) in the nasal passages.

    What are Dymista 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.

    Which are Dymista UNII Codes?

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

    Which are Dymista 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. The UNII codes for the inactive ingredients in this product are:

    What is the NDC to RxNorm Crosswalk for Dymista?

    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: 1797847 - azelastine HCl 137 MCG/ACTUAT / fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal Spray
    • RxCUI: 1797847 - azelastine hydrochloride 0.137 MG/ACTUAT / fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal Spray
    • RxCUI: 1797849 - Dymista 137/50 MCG/ACTUAT Metered Dose Nasal Spray
    • RxCUI: 1797849 - azelastine hydrochloride 0.137 MG/ACTUAT / fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal Spray [Dymista]
    • RxCUI: 1797849 - Dymista (azelastine hydrochloride 137 MCG/ACTUAT / fluticasone propionate 50 MCG/ACTUAT) Metered Dose Nasal Spray

    Which are the Pharmacologic Classes for Dymista?

    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.

    Patient Education

    Azelastine Nasal Spray


    Prescription and nonprescription (over the counter) azelastine nasal spray is used to relieve symptoms of rhinitis such as sneezing and a runny, stuffy, or itchy nose and itchy, watery eyes caused by hay fever or other allergies (caused by an allergy to pollen, mold, dust, or pets). Prescription azelastine nasal spray is also used to relieve symptoms of nonallergic rhinitis such as sneezing and runny or stuffy nose which are not caused by allergies in adults and children 12 years of age or older. Azelastine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.
    [Learn More]


    Fluticasone Nasal Spray


    Nonprescription (over the counter) fluticasone nasal spray is used to relieve symptoms of rhinitis such as sneezing and a runny, stuffy, or itchy nose and itchy, watery eyes caused by hay fever or other allergies (caused by an allergy to pollen, mold, dust, or pets). Prescription fluticasone nasal spray is used to relieve symptoms of nonallergic rhinitis such as sneezing and runny or stuffy nose which are not caused by allergies. Prescription fluticasone nasal spray (Xhance) is used to treat nasal polyps (swelling of the lining of the nose). Fluticasone nasal spray should not be used to treat symptoms (e.g., sneezing, stuffy, runny, itchy nose) caused by the common cold. Fluticasone is in a class of medications called corticosteroids. It works by blocking the release of certain natural substances that cause allergy symptoms.
    [Learn More]


    * Please review the disclaimer below.

    Product Footnotes

    [1] 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.

    [2] 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.

    [3] 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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] 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.

    [8] 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.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] 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.

    [12] 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".