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  5. NDC Package Code: 54868-5305-0 Amnesteem

NDC Package 54868-5305-0 Amnesteem

View Billable Units, 11-Digit Format, RxNorm

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 discontinued by the firm.

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
54868-5305-0
Package Description:
30 CAPSULE in 1 BOTTLE
Product Code:
54868-5305
Proprietary Name:
Amnesteem
Usage Information:
This medication is used to treat severe cystic acne (also known as nodular acne) that has not responded to other treatment (e.g., benzoyl peroxide or clindamycin applied to the skin or tetracycline or minocycline taken by mouth). It belongs to a class of drugs known as retinoids. It works by decreasing facial oil (sebum) production. High amounts of sebum can lead to severe acne. If left untreated, severe acne may cause permanent scarring.
11-Digit NDC Billing Format:
54868530500
Labeler Name:
Physicians Total Care, Inc.
Sample Package:
No
FDA Application Number:
ANDA075945
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
05-20-2005
End Marketing Date:
06-25-2012
Listing Expiration Date:
06-25-2012
Exclude Flag:
D
Code Structure:

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 disclaimer below.

Frequently Asked Questions

What is NDC 54868-5305-0?

The NDC Packaged Code 54868-5305-0 is assigned to a package of 30 capsule in 1 bottle of Amnesteem, labeled by Physicians Total Care, Inc.. The product's dosage form is and is administered via form.

Is NDC 54868-5305 included in the NDC Directory?

No, Amnesteem with product code 54868-5305 is excluded from the NDC Directory because it was discontinued by the manufacturer. The product was first marketed by Physicians Total Care, Inc. on May 20, 2005 and its listing in the NDC Directory is set to expire on June 25, 2012 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 54868-5305-0?

The 11-digit format is 54868530500. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-4-1 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-4-154868-5305-05-4-254868-5305-00