Fluocinolone Acetonide Implant
NDC Package 71071-001-01

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.

Fluocinolone Acetonide Implant implants is this shampoo is used to treat severe dandruff (seborrheic dermatitis). This formulation utilizes a implant delivery system. Marketed by Bausch Health Ireland Limited, this product is identified by NDC 71071-001.

Identification & Billing

NDC Package Code
71071-001-01
Package Description
50 CARTON in 1 BOX / .59 mg in 1 CARTON
Product Code
71071-001
11-Digit Billing Format
71071000101

Clinical Specifications

Proprietary Name
Fluocinolone Acetonide Implant
Non-Proprietary Name
Fluocinolone Acetonide Implant
Substance Name
Fluocinolone Acetonide
Dosage Form
Implant - A material containing drug intended to be inserted securely of deeply in a living site for growth, slow release, or formation of an organic union.
Active Ingredient(s)
FLUOCINOLONE ACETONIDE .59 mg/.59mg
Usage Information
This shampoo is used to treat severe dandruff (seborrheic dermatitis). Fluocinolone reduces the swelling, itching, flaking, and redness that can occur with dandruff. This medication is a low- to medium-strength corticosteroid.

Regulatory & Marketing

Labeler Name
Bausch Health Ireland Limited
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
08-08-2008
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 71071-001-01 identifies a specific commercial package of 50 carton in 1 box / .59 mg in 1 carton of Fluocinolone Acetonide Implant (UNFINISHED drug), a bulk ingredient labeled by Bausch Health Ireland Limited. This implant is formulated for use and contains fluocinolone acetonide 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 Bausch Health Ireland Limited on August 08, 2008. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This shampoo is used to treat severe dandruff (seborrheic dermatitis). Fluocinolone reduces the swelling, itching, flaking, and redness that can occur with dandruff. This medication is a low- to medium-strength corticosteroid.

How is this Bausch Health Ireland Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71071000101. 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 (5-3-2)
71071-001-01
11-Digit CMS (5-4-2)
71071-0001-01

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