NDC 78206-127 Dulera
Mometasone Furoate And Formoterol Fumarate Dihydrate Aerosol Respiratory (inhalation) - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
- 78206 - Organon Llc
- 78206-127 - Dulera
Product Packages
NDC Code 78206-127-01
Package Description: 1 CANISTER in 1 CARTON / 120 AEROSOL in 1 CANISTER
Price per Unit: $25.26184 per GM
NDC Code 78206-127-02
Package Description: 1 CANISTER in 1 CARTON / 60 AEROSOL in 1 CANISTER
Price per Unit: $25.24250 per GM
NDC Code 78206-127-59
Package Description: 1 CANISTER in 1 CARTON / 60 AEROSOL in 1 CANISTER
Product Details
What is NDC 78206-127?
What are the uses for Dulera?
What are Dulera Active Ingredients?
- FORMOTEROL FUMARATE 5 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.
- MOMETASONE FUROATE 100 ug/1 - A pregnadienediol derivative ANTI-ALLERGIC AGENT and ANTI-INFLAMMATORY AGENT that is used in the management of ASTHMA and ALLERGIC RHINITIS. It is also used as a topical treatment for skin disorders.
Which are Dulera UNII Codes?
The UNII codes for the active ingredients in this product are:
- MOMETASONE FUROATE (UNII: 04201GDN4R)
- MOMETASONE (UNII: 8HR4QJ6DW8) (Active Moiety)
- FORMOTEROL FUMARATE (UNII: W34SHF8J2K)
- FORMOTEROL (UNII: 5ZZ84GCW8B) (Active Moiety)
Which are Dulera 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:
- ALCOHOL (UNII: 3K9958V90M)
- OLEIC ACID (UNII: 2UMI9U37CP)
What is the NDC to RxNorm Crosswalk for Dulera?
- RxCUI: 1246308 - mometasone furoate/formoterol fumarate 100/5 MCG/INHAL Metered Dose Inhaler, 120 Actuations
- RxCUI: 1246308 - 120 ACTUAT formoterol fumarate 0.005 MG/ACTUAT / mometasone furoate 0.1 MG/ACTUAT Metered Dose Inhaler
- RxCUI: 1246308 - formoterol fumarate 0.005 MG / mometasone furoate 0.1 MG per ACTUAT Metered Dose Inhaler, 120 ACTUAT
- RxCUI: 1246308 - formoterol fumarate 5 MCG / mometasone furoate 100 MCG per ACTUAT Metered Dose Inhaler, 120 ACTUAT
- RxCUI: 1246310 - Dulera 100/5 MCG/INHAL Metered Dose Inhaler, 120 Actuations
Which are the Pharmacologic Classes for Dulera?
* Please review the disclaimer below.
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]
Mometasone Oral Inhalation
Mometasone oral inhalation is used to prevent difficulty breathing, chest tightness, wheezing, and coughing caused by asthma. Mometasone oral inhalation (Asmanex® HFA) is used in adults and children 12 years of age and older. Mometasone powder for oral inhalation (Asmanex® Twisthaler) is used in adults and children 4 years of age and older. It is in a class of medications called corticosteroids. Mometasone works by decreasing swelling and irritation in the airways to allow for easier breathing.
[Learn More]
* Please review the disclaimer below.
[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".