Yutiq Implant
NDC Package 68611-180-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Yutiq (fluocinolone acetonide) implants is this shampoo is used to treat severe dandruff (seborrheic dermatitis). This formulation utilizes a implant delivery system. Marketed by Ani Pharmaceuticals, Inc., this product is identified by NDC 68611-180 and is authorized under FDA application NDA210331.

Identification & Billing

NDC Package Code
68611-180-01
Package Description
1 POUCH in 1 CARTON / 1 APPLICATOR in 1 POUCH / 1 IMPLANT in 1 APPLICATOR
Product Code
68611-180
11-Digit Billing Format
68611018001
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Yutiq
Non-Proprietary Name
Fluocinolone Acetonide
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.
Administration Route
Intravitreal - Administration within the vitreous body of the eye.
Active Ingredient(s)
FLUOCINOLONE ACETONIDE .18 mg/1
Pharmacologic Class
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
Ani Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA210331
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-17-2023
Listing Expiration
12-31-2027
Exclude Flag
N
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 68611-180-01 identifies a specific commercial package of 1 pouch in 1 carton / 1 applicator in 1 pouch / 1 implant in 1 applicator of Yutiq, a human prescription drug labeled by Ani Pharmaceuticals, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This implant is formulated for intravitreal 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 Ani Pharmaceuticals, Inc. on May 17, 2023. The current certification is valid through December 31, 2027.

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 Ani Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68611018001. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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 (5-3-2)
68611-180-01
11-Digit CMS (5-4-2)
68611-0180-01

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