Azelastine Hydrochloride Solution/ Drops
NDC Package 46708-506-06

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Azelastine Hydrochloride solution/ dropses is azelastine hydrochloride ophthalmic solution 0.05% is indicated for the treatment of itching of the eye associated with allergic conjunctivitis. This formulation utilizes a solution/ drops delivery system. Marketed by Alembic Pharmaceuticals Limited, this product is identified by NDC 46708-506 and is authorized under FDA application ANDA209620.

Identification & Billing

NDC Package Code
46708-506-06
Package Description
1 BOTTLE in 1 CARTON / 6 mL in 1 BOTTLE
Product Code
46708-506
11-Digit Billing Format
46708050606
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Azelastine Hydrochloride
Non-Proprietary Name
Azelastine Hydrochloride
Substance Name
Azelastine Hydrochloride
Dosage Form
Solution/ Drops - A solution which is usually administered in a drop-wise fashion.
Administration Route
Ophthalmic - Administration to the external eye.
Active Ingredient(s)
AZELASTINE HYDROCHLORIDE .5 mg/mL
Pharmacologic Class
Usage Information
Azelastine hydrochloride ophthalmic solution 0.05% is indicated for the treatment of itching of the eye associated with allergic conjunctivitis.

Regulatory & Marketing

Labeler Name
Alembic Pharmaceuticals Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA209620
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-20-2019
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 46708-506-06 identifies a specific commercial package of 1 bottle in 1 carton / 6 ml in 1 bottle of Azelastine Hydrochloride, a human prescription drug labeled by Alembic Pharmaceuticals Limited. This solution/ drops is formulated for ophthalmic use and contains azelastine hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Alembic Pharmaceuticals Limited on March 20, 2019. The current certification is valid through December 31, 2026.

How is this Alembic Pharmaceuticals Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 46708050606. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
46708-506-06
11-Digit CMS (5-4-2)
46708-0506-06

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.