Sohonos Capsule
NDC Package 15054-0010-1

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

Package Information

Sohonos (palovarotene) capsules is sOHONOS is indicated for the reduction in volume of new heterotopic ossification in adults and pediatric patients aged 8 years and older for females and 10 years and older for males with fibrodysplasia ossificans progressiva (FOP). This formulation utilizes a capsule delivery system. Marketed by Ipsen Biopharmaceuticals, Inc., this product is identified by NDC 15054-0010 and is authorized under FDA application NDA215559.

Identification & Billing

NDC Package Code
15054-0010-1
Package Description
1 BLISTER PACK in 1 CARTON / 14 CAPSULE in 1 BLISTER PACK
Product Code
15054-0010
11-Digit Billing Format
15054001001
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
Sohonos
Non-Proprietary Name
Palovarotene
Substance Name
Palovarotene
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.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
PALOVAROTENE 1 mg/1
Pharmacologic Class
Usage Information
SOHONOS is indicated for the reduction in volume of new heterotopic ossification in adults and pediatric patients aged 8 years and older for females and 10 years and older for males with fibrodysplasia ossificans progressiva (FOP).

Regulatory & Marketing

Labeler Name
Ipsen Biopharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA215559
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-16-2023
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 15054-0010-1 identifies a specific commercial package of 1 blister pack in 1 carton / 14 capsule in 1 blister pack of Sohonos, a human prescription drug labeled by Ipsen Biopharmaceuticals, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This capsule is formulated for oral use and contains palovarotene 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 Ipsen Biopharmaceuticals, Inc. on August 16, 2023. The current certification is valid through December 31, 2026.

How is this Ipsen Biopharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 15054001001. 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 (5-4-1)
15054-0010-1
11-Digit CMS (5-4-2)
15054-0010-01

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