Hydrocortisone And Acetic Acid
NDC Package 50383-901-10

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.

Hydrocortisone And Acetic Acid is for the treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the antimicrobial, complicated by inflammation. Marketed by Akorn Operating Company Llc, this product is identified by NDC 50383-901 and is authorized under FDA application NDA012770.

Identification & Billing

NDC Package Code
50383-901-10
Package Description
1 BOTTLE, DROPPER in 1 CARTON / 10 mL in 1 BOTTLE, DROPPER
Product Code
50383-901
11-Digit Billing Format
50383090110
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 313786 - acetic acid 2 % / hydrocortisone 1 % Otic Solution
  • RxCUI: 313786 - acetic acid 20 MG/ML / hydrocortisone 10 MG/ML Otic Solution

Clinical Specifications

Proprietary Name
Hydrocortisone And Acetic Acid
Dosage Form
-
Usage Information
For the treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the antimicrobial, complicated by inflammation.

Regulatory & Marketing

Labeler Name
Akorn Operating Company Llc
FDA Application #
NDA012770
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-04-2009
Listing Expiration
12-31-2023
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 50383-901-10 identifies a specific commercial package of 1 bottle, dropper in 1 carton / 10 ml in 1 bottle, dropper of Hydrocortisone And Acetic Acid, labeled by Akorn Operating Company Llc. 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 Akorn Operating Company Llc on June 04, 2009. The current certification is valid through December 31, 2023.

How is this Akorn Operating Company Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50383090110. 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 (5-3-2)
50383-901-10
11-Digit CMS (5-4-2)
50383-0901-10

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