Astepro Allergy
Azelastine Hcl
Bayer Healthcare Llc.
Human Otc Drug
NDC 0280-0065Astepro Allergy also known as Azelastine Hcl is a human otc drug labeled by 'Bayer Healthcare Llc.'. National Drug Code (NDC) number for Astepro Allergy is 0280-0065. This drug is available in dosage form of Spray, Metered. The names of the active, medicinal ingredients in Astepro Allergy drug includes Azelastine Hydrochloride - 205.5 ug/1 . The currest status of Astepro Allergy drug is Active.
Drug Information:
| Drug NDC: | 0280-0065 |
| 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: | Astepro 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: | Azelastine Hcl |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Bayer Healthcare Llc. |
| 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: | AZELASTINE HYDROCHLORIDE - 205.5 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: | NDA |
| 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: | 27 Jun, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 10 May, 2026 |
| 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: | NDA213872 |
| 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, 2024 |
| 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: | Bayer HealthCare LLC.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1797883
1797884
|
| 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. |
| UNII: | 0L591QR10I
|
| 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: | Histamine H1 Receptor Antagonists [MoA]
Histamine-1 Receptor Antagonist [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 |
|---|
| 0280-0065-01 | 60 CARTON in 1 BOTTLE (0280-0065-01) / 1 SPRAY, METERED in 1 CARTON | 05 Jul, 2022 | N/A | Yes |
| 0280-0065-02 | 120 CARTON in 1 BOTTLE (0280-0065-02) / 1 SPRAY, METERED in 1 CARTON | 05 Jul, 2022 | N/A | No |
| 0280-0065-03 | 120 PACKAGE in 1 BOTTLE (0280-0065-03) / 3 SPRAY, METERED in 1 PACKAGE | 05 Jul, 2022 | N/A | No |
| 0280-0065-04 | 200 CARTON in 1 BOTTLE (0280-0065-04) / 1 SPRAY, METERED in 1 CARTON | 05 Jul, 2022 | N/A | No |
| 0280-0065-05 | 22 CARTON in 1 BOTTLE (0280-0065-05) / 1 SPRAY, METERED in 1 CARTON | 24 Jan, 2023 | N/A | Yes |
| 0280-0065-09 | 120 CARTON in 1 BOTTLE (0280-0065-09) / 2 SPRAY, METERED in 1 CARTON | 05 Jul, 2022 | N/A | No |
| 0280-0065-10 | 22 CARTON in 1 BOTTLE (0280-0065-10) / 1 SPRAY, METERED in 1 CARTON | 05 Jul, 2022 | 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 antihistamine
Product Elements:
Astepro allergy azelastine hcl benzalkonium chloride edetate disodium hypromelloses azelastine hydrochloride azelastine sodium citrate sorbitol sucralose water
Indications and Usage:
Uses uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: nasal congestion runny nose sneezing itchy nose
Warnings:
Warnings only for use in the nose. do not spray in eyes or mouth. do not use if you have ever had an allergic reaction to this product or any of its 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 when using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery you may get a bitter taste in your mouth. to help avoid this, tilt your head downward while spraying. nasal discomfort or sneezing may occur right after use do not share this bottle with anyone else as this may spread germs stop use and ask a doctor if an allergic reaction, such as a skin rash, to this product occurs 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 cen
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Do Not Use:
Warnings only for use in the nose. do not spray in eyes or mouth. do not use if you have ever had an allergic reaction to this product or any of its 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 when using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery you may get a bitter taste in your mouth. to help avoid this, tilt your head downward while spraying. nasal discomfort or sneezing may occur right after use do not share this bottle with anyone else as this may spread germs stop use and ask a doctor if an allergic reaction, such as a skin rash, to this product occurs 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.
When Using:
When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery you may get a bitter taste in your mouth. to help avoid this, tilt your head downward while spraying. nasal discomfort or sneezing may occur right after use do not share this bottle with anyone else as this may spread germs
Dosage and Administration:
Directions read the user guide for how to: prime the bottle before first use prime bottle again if not used for 3 or more days use the spray clean the spray nozzle if it gets clogged adults and children 12 years and older this product may be used either once or twice a day: once daily : use 2 sprays in each nostril; or twice daily : use 1 or 2 sprays in each nostril every 12 hours do not use more than 4 sprays in each nostril in a 24 hour period children 6 years to 11 years an adult should supervise use 1 spray in each nostril every 12 hours do not use more than 2 sprays in each nostril in a 24 hour period children under 6 years do not use
Stop Use:
Stop use and ask a doctor if an allergic reaction, such as a skin rash, to this product occurs you have severe or frequent nosebleeds
Package Label Principal Display Panel:
Azelastine hcl 205.5 mcg per spray antihistamine nasal spray full prescription strength steroid free up to 24 hour relief of nasal congestion runny nose sneezing itchy nose astepro-120-artwork
Further Questions:
Questions or comments questions or comments? 1-800-317-2165 (mon-fri, 9am-5pm est)