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  4. NDC Product Code: 53002-2279 Azelastine Hydrochloride

NDC 53002-2279 Azelastine Hydrochloride

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 53002-2279?
  4. Azelastine Hydrochloride Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk
  8. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
53002-2279
Proprietary Name:
Azelastine Hydrochloride
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Rpk Pharmaceuticals, Inc.
Labeler Code:
53002
Product Label ID:
2ffdc506-c432-405c-91d5-0cabe7bcbf86
Start Marketing Date: [9]
05-24-2012
Listing Expiration Date: [11]
12-31-2023
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Packages

NDC Code 53002-2279-1

Package Description: 1 BOTTLE, SPRAY in 1 BOX / 200 SPRAY, METERED in 1 BOTTLE, SPRAY

Product Details

What is NDC 53002-2279?

The NDC code 53002-2279 is assigned by the FDA to the product Azelastine Hydrochloride which is product labeled by Rpk Pharmaceuticals, Inc.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 53002-2279-1 1 bottle, spray in 1 box / 200 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 Azelastine Hydrochloride?

Azelastine hydrochloride nasal solution (nasal spray), 0.1% (137 mcg per spray) is indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older, and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older.

Which are Azelastine Hydrochloride UNII Codes?

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

Which are Azelastine Hydrochloride 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 Azelastine Hydrochloride?

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: 1797867 - azelastine HCl 137 MCG/ACTUAT Metered Dose Nasal Spray
  • RxCUI: 1797867 - azelastine hydrochloride 0.137 MG/ACTUAT Metered Dose Nasal Spray

* 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.
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* Please review the disclaimer below.

Product Footnotes

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

[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".