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  5. NDC Package Code: 0280-0065-01 Astepro Allergy

NDC Package 0280-0065-01 Astepro Allergy

Azelastine Hcl Spray, Metered Nasal - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
0280-0065-01
Package Description:
60 CARTON in 1 BOTTLE / 1 SPRAY, METERED in 1 CARTON
Product Code:
0280-0065
Proprietary Name:
Astepro Allergy
Non-Proprietary Name:
Azelastine Hcl
Substance Name:
Azelastine Hydrochloride
Usage Information:
This medication is used to relieve nasal symptoms such as runny/itching/stuffy nose, sneezing, and post-nasal drip caused by allergies or other conditions. Azelastine belongs to a class of drugs known as antihistamines. It works by blocking certain natural substances called histamines that are responsible for nasal symptoms.
11-Digit NDC Billing Format:
00280006501
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1797883 - azelastine HCl 205.5 MCG/ACTUAT Metered Dose Nasal Spray
  • RxCUI: 1797883 - azelastine hydrochloride 0.206 MG/ACTUAT Metered Dose Nasal Spray
  • RxCUI: 1797884 - Astepro 205.5 MCG/ACTUAT Metered Dose Nasal Spray
  • RxCUI: 1797884 - azelastine hydrochloride 0.206 MG/ACTUAT Metered Dose Nasal Spray [Astepro]
  • RxCUI: 1797884 - Astepro 0.206 MG/ACTUAT Metered Dose Nasal Spray
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Bayer Healthcare Llc.
    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):
  • Nasal - Administration to the nose; administered by way of the nose.
    • Active Ingredient(s):
  • AZELASTINE HYDROCHLORIDE 205.5 ug/1
    • Pharmacologic Class(es):
  • Histamine H1 Receptor Antagonists - [MoA] (Mechanism of Action)
  • Histamine-1 Receptor Antagonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    Yes
    FDA Application Number:
    NDA213872
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    06-27-2022
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

    * Please review the disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    0280-0065-02120 CARTON in 1 BOTTLE / 1 SPRAY, METERED in 1 CARTON
    0280-0065-03120 PACKAGE in 1 BOTTLE / 3 SPRAY, METERED in 1 PACKAGE
    0280-0065-04200 CARTON in 1 BOTTLE / 1 SPRAY, METERED in 1 CARTON
    0280-0065-0522 CARTON in 1 BOTTLE / 1 SPRAY, METERED in 1 CARTON
    0280-0065-09120 CARTON in 1 BOTTLE / 2 SPRAY, METERED in 1 CARTON
    0280-0065-1022 CARTON in 1 BOTTLE / 1 SPRAY, METERED in 1 CARTON

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0280-0065-01?

    The NDC Packaged Code 0280-0065-01 is assigned to a package of 60 carton in 1 bottle / 1 spray, metered in 1 carton of Astepro Allergy, a human over the counter drug labeled by Bayer Healthcare Llc.. The product's dosage form is spray, metered and is administered via nasal form.

    Is NDC 0280-0065 included in the NDC Directory?

    Yes, Astepro Allergy with product code 0280-0065 is active and included in the NDC Directory. The product was first marketed by Bayer Healthcare Llc. on June 27, 2022 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 0280-0065-01?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 0280-0065-01?

    The 11-digit format is 00280006501. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    4-4-20280-0065-015-4-200280-0065-01