Acetic Acid
NDC Package 50436-4600-1

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Acetic Acid is used to treat an outer ear infection (external otitis). Marketed by Unit Dose Services, this product is identified by NDC 50436-4600 and is authorized under FDA application ANDA040166.

Identification & Billing

NDC Package Code
50436-4600-1
Package Description
15 mL in 1 BOTTLE
Product Code
50436-4600
11-Digit Billing Format
50436460001
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Acetic Acid
Dosage Form
-
Usage Information
Acetic acid is used to treat an outer ear infection (external otitis). It works by stopping the growth of bacteria and fungus. Treating the infection reduces pain and swelling in the ear. Wetness in the ear canal can help bacteria and fungus to grow. This medication may also contain drying ingredients such as glycerin or alcohol. Drying of the ear canal helps to cure the infection.

Regulatory & Marketing

Labeler Name
Unit Dose Services
FDA Application #
ANDA040166
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-26-1996
Listing Expiration
12-31-2020
Exclude Flag
I
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 50436-4600-1 identifies a specific commercial package of 15 ml in 1 bottle of Acetic Acid, labeled by Unit Dose Services. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Unit Dose Services on July 26, 1996. The current certification is valid through December 31, 2020.

What are the primary indications for this medication?

Acetic acid is used to treat an outer ear infection (external otitis). It works by stopping the growth of bacteria and fungus. Treating the infection reduces pain and swelling in the ear. Wetness in the ear canal can help bacteria and fungus to grow. This medication may also contain drying ingredients such as glycerin or alcohol. Drying of the ear canal helps to cure the infection.

How is this Unit Dose Services product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50436460001. 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 (5-4-1)
50436-4600-1
11-Digit CMS (5-4-2)
50436-4600-01

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