Otezla
NDC Package 70518-3155-0

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.

Otezla is a medication used to treat a certain type of arthritis (psoriatic arthritis). Marketed by Remedyrepack Inc., this product is identified by NDC 70518-3155 and is authorized under FDA application NDA205437.

Identification & Billing

NDC Package Code
70518-3155-0
Package Description
30 POUCH in 1 BOX / 1 TABLET, FILM COATED in 1 POUCH (70518-3155-1)
Product Code
70518-3155
11-Digit Billing Format
70518315500

Clinical Specifications

Proprietary Name
Otezla
Dosage Form
-
Usage Information
This medication is used to treat a certain type of arthritis (psoriatic arthritis). Apremilast is also used to treat a certain type of skin condition (moderate to severe plaque psoriasis). Apremilast belongs to a class of drugs known as phosphodiesterase 4 (PDE4) inhibitors. For the treatment of psoriatic arthritis, it decreases pain and swelling, and may help improve flexibility in the affected joints. For the treatment of plaque psoriasis, it may help to reduce the redness, thickening, and scaling of the skin that occurs with this condition. Apremilast is also used to treat mouth sores in people who have Behcet's disease. It helps to reduce the pain and improve the healing of these mouth sores.

Regulatory & Marketing

Labeler Name
Remedyrepack Inc.
FDA Application #
NDA205437
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-14-2021
End Marketing Date
10-13-2021
Listing Expiration
10-13-2021
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 70518-3155-0 identifies a specific commercial package of 30 pouch in 1 box / 1 tablet, film coated in 1 pouch (70518-3155-1) of Otezla, labeled by Remedyrepack 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 Remedyrepack Inc. on July 14, 2021. The current certification is valid through October 13, 2021.

What are the primary indications for this medication?

This medication is used to treat a certain type of arthritis (psoriatic arthritis). Apremilast is also used to treat a certain type of skin condition (moderate to severe plaque psoriasis). Apremilast belongs to a class of drugs known as phosphodiesterase 4 (PDE4) inhibitors. For the treatment of psoriatic arthritis, it decreases pain and swelling, and may help improve flexibility in the affected joints. For the treatment of plaque psoriasis, it may help to reduce the redness, thickening, and scaling of the skin that occurs with this condition. Apremilast is also used to treat mouth sores in people who have Behcet's disease. It helps to reduce the pain and improve the healing of these mouth sores.

How is this Remedyrepack Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70518315500. 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)
70518-3155-0
11-Digit CMS (5-4-2)
70518-3155-00

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