Tazarotene Aerosol, Foam
NDC Package 68308-685-50

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

Package Information

Tazarotene aerosols is tazarotene is used to treat psoriasis or acne. This formulation utilizes a aerosol, foam delivery system. Marketed by Mayne Pharma Inc., this product is identified by NDC 68308-685 and is authorized under FDA application NDA202428.

Identification & Billing

NDC Package Code
68308-685-50
Package Description
1 CAN in 1 CARTON / 50 g in 1 CAN
Product Code
68308-685
11-Digit Billing Format
68308068550
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
50 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Tazarotene
Non-Proprietary Name
Tazarotene
Substance Name
Tazarotene
Dosage Form
Aerosol, Foam - A dosage form containing one or more active ingredients, surfactants, aqueous or nonaqueous liquids, and the propellants; if the propellant is in the internal (discontinuous) phase (i.e., of the oil-in-water type), a stable foam is discharged, and if the propellant is in the external (continuous) phase (i.e., of the water-in-oil type), a spray or a quick-breaking foam is discharged.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
TAZAROTENE 1 mg/g
Pharmacologic Class
Usage Information
Tazarotene is used to treat psoriasis or acne. It is a retinoid product related to Vitamin A. It works by affecting the growth of skin cells. The foam and lotion forms of this medication are only approved for use on acne.

Regulatory & Marketing

Labeler Name
Mayne Pharma Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA202428
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
04-23-2021
Listing Expiration
12-31-2026
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 68308-685-50 identifies a specific commercial package of 1 can in 1 carton / 50 g in 1 can of Tazarotene, a human prescription drug labeled by Mayne Pharma Inc.. This product is billed per "GM" gram and contains an estimated amount of 50 billable units per package. This aerosol, foam is formulated for topical use and contains tazarotene 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 Mayne Pharma Inc. on April 23, 2021. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Tazarotene is used to treat psoriasis or acne. It is a retinoid product related to Vitamin A. It works by affecting the growth of skin cells. The foam and lotion forms of this medication are only approved for use on acne.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68308068550. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 50 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)
68308-685-50
11-Digit CMS (5-4-2)
68308-0685-50

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