Acitretin
NDC Package 0591-2263-30

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 discontinued by the firm.

Acitretin is a medication a retinoid used in the treatment of severe psoriasis and other skin disorders in adults. Marketed by Actavis Pharma, Inc., this product is identified by NDC 0591-2263 and is authorized under FDA application ANDA202552.

Identification & Billing

NDC Package Code
0591-2263-30
Package Description
30 CAPSULE in 1 BOTTLE, PLASTIC
Product Code
0591-2263
11-Digit Billing Format
00591226330
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA

Clinical Specifications

Proprietary Name
Acitretin
Dosage Form
-
Usage Information
This medication is a retinoid used in the treatment of severe psoriasis and other skin disorders in adults.

Regulatory & Marketing

Labeler Name
Actavis Pharma, Inc.
FDA Application #
ANDA202552
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-11-2016
End Marketing Date
05-31-2018
Listing Expiration
05-31-2018
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0591-2263-30 identifies a specific commercial package of 30 capsule in 1 bottle, plastic of Acitretin, labeled by Actavis Pharma, Inc.. 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 Actavis Pharma, Inc. on February 11, 2016. The current certification is valid through May 31, 2018.

What are the primary indications for this medication?

This medication is a retinoid used in the treatment of severe psoriasis and other skin disorders in adults.

How is this Actavis Pharma, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00591226330. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 total billable units per package. 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)
0591-2263-30
11-Digit CMS (5-4-2)
00591-2263-30

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