Acitretin Capsule
NDC Package 71214-0669-1

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Acitretin capsules is a medication a retinoid used in the treatment of severe psoriasis and other skin disorders in adults. This formulation utilizes a capsule delivery system. Marketed by Micro-sphere Sa, this product is identified by NDC 71214-0669.

Identification & Billing

NDC Package Code
71214-0669-1
Package Description
10000 CAPSULE in 1 BAG
Product Code
71214-0669
11-Digit Billing Format
71214066901

Clinical Specifications

Proprietary Name
Acitretin
Non-Proprietary Name
Acitretin
Substance Name
Acitretin
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Active Ingredient(s)
ACITRETIN 25 mg/1
Usage Information
This medication is a retinoid used in the treatment of severe psoriasis and other skin disorders in adults.

Regulatory & Marketing

Labeler Name
Micro-sphere Sa
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
05-30-2017
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 71214-0669-1 identifies a specific commercial package of 10000 capsule in 1 bag of Acitretin (UNFINISHED drug), drug for further processing labeled by Micro-sphere Sa. This capsule is formulated for use and contains acitretin as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Micro-sphere Sa on May 30, 2017. The current certification is valid through December 31, 2026.

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 Micro-sphere Sa product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71214066901. 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 (5-4-1)
71214-0669-1
11-Digit CMS (5-4-2)
71214-0669-01

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