Colocort
NDC Package 0574-2020-01

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

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Colocort is a medication used to treat the symptoms of a certain intestinal problem called ulcerative colitis. Marketed by Paddock Laboratories, Llc, this product is identified by NDC 0574-2020 and is authorized under FDA application ANDA075172.

Identification & Billing

NDC Package Code
0574-2020-01
Package Description
1 BOTTLE, WITH APPLICATOR in 1 CARTON / 60 mL in 1 BOTTLE, WITH APPLICATOR
Product Code
0574-2020
11-Digit Billing Format
00574202001
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Colocort
Dosage Form
-
Usage Information
This medication is used to treat the symptoms of a certain intestinal problem called ulcerative colitis. It is not a cure for this condition, but it is usually used with other treatments to manage this problem. Hydrocortisone enemas help to decrease diarrhea and bloody stools by reducing swelling (inflammation) in the rectum and colon. Hydrocortisone belongs to a class of drugs called corticosteroids.

Regulatory & Marketing

Labeler Name
Paddock Laboratories, Llc
FDA Application #
ANDA075172
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-31-1999
End Marketing Date
04-30-2019
Listing Expiration
04-30-2019
Exclude Flag
D
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 (0574-2020). Click a package code to view its specific billing and regulatory data.

0574-2020-07
7 BOTTLE, WITH APPLICATOR in 1 CARTON / 60 mL in 1 BOTTLE, WITH APPLICATOR

* 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 0574-2020-01 identifies a specific commercial package of 1 bottle, with applicator in 1 carton / 60 ml in 1 bottle, with applicator of Colocort, labeled by Paddock Laboratories, 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 Paddock Laboratories, Llc on December 31, 1999. The current certification is valid through April 30, 2019.

What are the primary indications for this medication?

This medication is used to treat the symptoms of a certain intestinal problem called ulcerative colitis. It is not a cure for this condition, but it is usually used with other treatments to manage this problem. Hydrocortisone enemas help to decrease diarrhea and bloody stools by reducing swelling (inflammation) in the rectum and colon. Hydrocortisone belongs to a class of drugs called corticosteroids.

How is this Paddock Laboratories, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00574202001. 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)
0574-2020-01
11-Digit CMS (5-4-2)
00574-2020-01

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