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  4. NDC Product Code: 50383-901 Hydrocortisone And Acetic Acid

NDC 50383-901 Hydrocortisone And Acetic Acid

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 50383-901?
  4. Hydrocortisone And Acetic Acid Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
50383-901
Proprietary Name:
Hydrocortisone And Acetic Acid
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Akorn Operating Company Llc
Labeler Code:
50383
Product Label ID:
ffd1edc1-2f40-4b0a-a53a-9fb53b8d3184
Start Marketing Date: [9]
06-04-2009
Listing Expiration Date: [11]
12-31-2023
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Packages

NDC Code 50383-901-10

Package Description: 1 BOTTLE, DROPPER in 1 CARTON / 10 mL in 1 BOTTLE, DROPPER

Price per Unit: $8.10413 per ML

Product Details

What is NDC 50383-901?

The NDC code 50383-901 is assigned by the FDA to the product Hydrocortisone And Acetic Acid which is product labeled by Akorn Operating Company Llc. The product's dosage form is . The product is distributed in a single package with assigned NDC code 50383-901-10 1 bottle, dropper in 1 carton / 10 ml in 1 bottle, dropper. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Hydrocortisone And Acetic Acid?

For the treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the antimicrobial, complicated by inflammation.

Which are Hydrocortisone And Acetic Acid UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Hydrocortisone And Acetic Acid Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Hydrocortisone And Acetic Acid?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 313786 - acetic acid 2 % / hydrocortisone 1 % Otic Solution
  • RxCUI: 313786 - acetic acid 20 MG/ML / hydrocortisone 10 MG/ML Otic Solution

* Please review the disclaimer below.

Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".