Bepotastine Besilate Solution/ Drops
NDC Package 0378-7055-35

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

Package Information

Bepotastine Besilate solution/ dropses is a medication used to treat itching of the eyes due to allergies. This formulation utilizes a solution/ drops delivery system. Marketed by Mylan Pharmaceuticals Inc., this product is identified by NDC 0378-7055 and is authorized under FDA application ANDA206220.

Identification & Billing

NDC Package Code
0378-7055-35
Package Description
1 BOTTLE, DROPPER in 1 CARTON / 5 mL in 1 BOTTLE, DROPPER
Product Code
0378-7055
11-Digit Billing Format
00378705535
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Bepotastine Besilate
Non-Proprietary Name
Bepotastine Besilate
Substance Name
Bepotastine Besilate
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)
BEPOTASTINE BESILATE 15 mg/mL
Pharmacologic Class
Histamine-1 Receptor Antagonist - [EPC] (Established Pharmacologic Class)
Usage Information
This medication is used to treat itching of the eyes due to allergies. Bepotastine is an antihistamine. It works by blocking a certain natural substance (histamine) that causes allergic symptoms. Do not use this medication to treat red or irritated eyes due to wearing contact lenses. Contact your doctor for further instructions if this occurs.

Regulatory & Marketing

Labeler Name
Mylan Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA206220
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-28-2021
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0378-7055). Click a package code to view its specific billing and regulatory data.

0378-7055-67
1 BOTTLE, DROPPER in 1 CARTON / 10 mL in 1 BOTTLE, DROPPER

* 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 0378-7055-35 identifies a specific commercial package of 1 bottle, dropper in 1 carton / 5 ml in 1 bottle, dropper of Bepotastine Besilate, a human prescription drug labeled by Mylan Pharmaceuticals Inc.. This solution/ drops is formulated for ophthalmic use and contains bepotastine besilate 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 Mylan Pharmaceuticals Inc. on May 28, 2021. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat itching of the eyes due to allergies. Bepotastine is an antihistamine. It works by blocking a certain natural substance (histamine) that causes allergic symptoms. Do not use this medication to treat red or irritated eyes due to wearing contact lenses. Contact your doctor for further instructions if this occurs.

How is this Mylan Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00378705535. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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 (4-4-2)
0378-7055-35
11-Digit CMS (5-4-2)
00378-7055-35

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