NDC Package 69238-2147-3 Azelastine Hcl

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

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:
69238-2147-3
Package Description:
200 CARTON in 1 BOTTLE / 1 SPRAY, METERED in 1 CARTON
Product Code:
Proprietary Name:
Azelastine Hcl
Non-Proprietary Name:
Azelastine
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:
69238214703
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
Product Type:
Human Otc Drug
Labeler Name:
Amneal Pharmaceuticals Ny 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.
Sample Package:
No
FDA Application Number:
ANDA216576
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
06-07-2024
Listing Expiration Date:
12-31-2025
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.

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Frequently Asked Questions

What is NDC 69238-2147-3?

The NDC Packaged Code 69238-2147-3 is assigned to a package of 200 carton in 1 bottle / 1 spray, metered in 1 carton of Azelastine Hcl, a human over the counter drug labeled by Amneal Pharmaceuticals Ny Llc. The product's dosage form is spray, metered and is administered via nasal form.

Is NDC 69238-2147 included in the NDC Directory?

Yes, Azelastine Hcl with product code 69238-2147 is active and included in the NDC Directory. The product was first marketed by Amneal Pharmaceuticals Ny Llc on June 07, 2024 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 69238-2147-3?

The 11-digit format is 69238214703. 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 5-4-1 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
5-4-169238-2147-35-4-269238-2147-03