Nasal Allergy
Triamcinolone Acetonide
Cvs Pharmacy
Human Otc Drug
NDC 59779-746Nasal Allergy also known as Triamcinolone Acetonide is a human otc drug labeled by 'Cvs Pharmacy'. National Drug Code (NDC) number for Nasal Allergy is 59779-746. This drug is available in dosage form of Spray, Metered. The names of the active, medicinal ingredients in Nasal Allergy drug includes Triamcinolone Acetonide - 55 ug/1 . The currest status of Nasal Allergy drug is Active.
Drug Information:
| Drug NDC: | 59779-746 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Nasal Allergy |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Triamcinolone Acetonide |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Cvs Pharmacy |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Spray, Metered |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | TRIAMCINOLONE ACETONIDE - 55 ug/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | NASAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | ANDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 10 Apr, 2016 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 24 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | ANDA078104 |
| 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. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | CVS Pharmacy
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1797913
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| NUI: | N0000175576
N0000175450
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | F446C597KA
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class MOA: | Corticosteroid Hormone Receptor Agonists [MoA]
|
| Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`. |
| Pharmacologic Class EPC: | Corticosteroid [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class: | Corticosteroid Hormone Receptor Agonists [MoA]
Corticosteroid [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 59779-746-01 | 1 BOTTLE, SPRAY in 1 CARTON (59779-746-01) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY | 10 Apr, 2016 | N/A | No |
| 59779-746-02 | 1 BOTTLE, SPRAY in 1 CARTON (59779-746-02) / 60 SPRAY, METERED in 1 BOTTLE, SPRAY | 01 May, 2017 | N/A | No |
| 59779-746-03 | 2 BOTTLE, SPRAY in 1 CARTON (59779-746-03) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY | 13 Dec, 2016 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose allergy symptom reliever
Product Elements:
Nasal allergy triamcinolone acetonide triamcinolone acetonide triamcinolone acetonide benzalkonium chloride carboxymethylcellulose sodium, unspecified form anhydrous dextrose edetate disodium hydrochloric acid sodium hydroxide microcrystalline cellulose polysorbate 80 water off white
Indications and Usage:
Uses temporarily relieves these symptoms of hay fever or other upper respiratory allergies: ⢠nasal congestion ⢠runny nose ⢠sneezing ⢠itchy nose
Warnings:
Warnings do not use ⢠in children under 2 years of age ⢠if you have ever had an allergic reaction to any of the ingredients ask a doctor before use if you ⢠have had recent nose ulcers or nose surgery ⢠have had a nose injury that has not healed ⢠are using a steroid medicine for asthma, allergies or skin rash ⢠have an eye infection ⢠have or had glaucoma or cataracts when using this product ⢠the growth rate of some children may be slower ⢠some symptoms may get better on the first day of treatment. it may take up to one week of daily use to feel the most symptom relief. ⢠do not share this bottle with anyone else as this may spread germs ⢠remember to tell your doctor about all the medicines you take, including this one stop use and ask a doctor if ⢠you have, or come into contact with someone who has, chickenpox, measles or tuberculosis ⢠you have or develop symptoms of an infection such as a persistent fever â¢
Read more...you have any change in vision ⢠you have severe or frequent nosebleeds if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away (1-800-222-1222).
Do Not Use:
Warnings do not use ⢠in children under 2 years of age ⢠if you have ever had an allergic reaction to any of the ingredients ask a doctor before use if you ⢠have had recent nose ulcers or nose surgery ⢠have had a nose injury that has not healed ⢠are using a steroid medicine for asthma, allergies or skin rash ⢠have an eye infection ⢠have or had glaucoma or cataracts when using this product ⢠the growth rate of some children may be slower ⢠some symptoms may get better on the first day of treatment. it may take up to one week of daily use to feel the most symptom relief. ⢠do not share this bottle with anyone else as this may spread germs ⢠remember to tell your doctor about all the medicines you take, including this one stop use and ask a doctor if ⢠you have, or come into contact with someone who has, chickenpox, measles or tuberculosis ⢠you have or develop symptoms of an infection such as a persistent fever ⢠you have any change in vision ⢠you have severe or frequent nosebleeds if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away (1-800-222-1222).
When Using:
When using this product ⢠the growth rate of some children may be slower ⢠some symptoms may get better on the first day of treatment. it may take up to one week of daily use to feel the most symptom relief. ⢠do not share this bottle with anyone else as this may spread germs ⢠remember to tell your doctor about all the medicines you take, including this one
Dosage and Administration:
Directions read insert (inside package) on how to: ⢠get a new bottle ready (primed) before first use ⢠prime bottle again if not used for more than 2 weeks ⢠use the spray ⢠clean the spray nozzle adults and children 12 years of age and older adults and children 12 years of age and older ⢠once daily, spray 2 times into each nostril while sniffing gently ⢠once your allergy symptoms improve, reduce to 1 spray in each nostril per day children 2 to under 12 years of age ⢠the growth rate of some children may be slower while using this product. talk to your childâs doctor if your child needs to use the spray for longer than two months a year. children 6 to under 12 years of age ⢠an adult should supervise use ⢠once daily, spray 1 time into each nostril while sniffing gently ⢠if allergy symptoms do not improve, increase to 2 sprays in each nostril per day. once allergy symptoms improve, reduce to 1 spray in each nostril per day. chi
Read more...ldren 2 to under 6 years of age ⢠an adult should supervise use ⢠once daily, spray 1 time into each nostril while sniffing gently children under 2 years of age ⢠do not use â do not use more than directed â if you forget a dose, do not double the next dose â do not spray into eyes or mouth â if allergy symptoms do not improve after one week, stop using and talk to a doctor â do not use for the common cold â shake well before each use
Stop Use:
Stop use and ask a doctor if ⢠you have, or come into contact with someone who has, chickenpox, measles or tuberculosis ⢠you have or develop symptoms of an infection such as a persistent fever ⢠you have any change in vision ⢠you have severe or frequent nosebleeds
Package Label Principal Display Panel:
Package/label principal display panel compare to the active ingredient in nasacort ® allergy 24hr original prescription strength multi-symptom nasal allergy spray triamcinolone acetonide nasal spray 55 mcg per spray allergy symptom reliever (glucocorticoid)â 24 hour 24 hour relief of: nasal congestion sneezing runny nose itchy nose non-drowsy scent free alcohol free actual size bottle on side panel â triamcinolone acetonide is a steroid medicine known as a glucocorticoid. 120 sprays 0.57 fl oz (16.9 ml) nasal allergy spray image
Further Questions:
Questions or comments? 1-800-719-9260