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  5. NDC Package Code: 47335-938-90 Azelastine Hydrochloride

NDC Package 47335-938-90 Azelastine Hydrochloride

Solution/ Drops Intraocular - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. 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:
47335-938-90
Package Description:
1 BOTTLE, PLASTIC in 1 BOX / 6 mL in 1 BOTTLE, PLASTIC
Product Code:
47335-938
Proprietary Name:
Azelastine Hydrochloride
Non-Proprietary Name:
Azelastine Hydrochloride
Substance Name:
Azelastine Hydrochloride
Usage Information:
Azelastine hydrochloride ophthalmic solution is indicated for the treatment of itching of the eye associated with allergic conjunctivitis.
11-Digit NDC Billing Format:
47335093890
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 860805 - azelastine HCl 0.05 % Ophthalmic Solution
  • RxCUI: 860805 - azelastine hydrochloride 0.5 MG/ML Ophthalmic Solution
  • RxCUI: 860805 - azelastine hydrochloride 0.05 % Ophthalmic Solution
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Sun Pharmaceutical Industries, Inc.
    Dosage Form:
    Solution/ Drops - A solution which is usually administered in a drop-wise fashion.
    Administration Route(s):
  • Intraocular - Administration within the eye.
    • Active Ingredient(s):
  • AZELASTINE HYDROCHLORIDE .5 mg/mL
    • Pharmacologic Class(es):
  • Histamine H1 Receptor Antagonists - [MoA] (Mechanism of Action)
  • Histamine-1 Receptor Antagonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA078738
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    05-31-2010
    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.

    Frequently Asked Questions

    What is NDC 47335-938-90?

    The NDC Packaged Code 47335-938-90 is assigned to a package of 1 bottle, plastic in 1 box / 6 ml in 1 bottle, plastic of Azelastine Hydrochloride, a human prescription drug labeled by Sun Pharmaceutical Industries, Inc.. The product's dosage form is solution/ drops and is administered via intraocular form.

    Is NDC 47335-938 included in the NDC Directory?

    Yes, Azelastine Hydrochloride with product code 47335-938 is active and included in the NDC Directory. The product was first marketed by Sun Pharmaceutical Industries, Inc. on May 31, 2010 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 47335-938-90?

    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 47335-938-90?

    The 11-digit format is 47335093890. 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 5-3-2 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
    5-3-247335-938-905-4-247335-0938-90