Scenesse Implant
NDC Package 73372-0116-1

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

Package Information

Scenesse (afamelanotide) implants is sCENESSE® is indicated to increase pain free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP). This formulation utilizes a implant delivery system. Marketed by Clinuvel Inc., this product is identified by NDC 73372-0116 and is authorized under FDA application NDA210797.

Identification & Billing

NDC Package Code
73372-0116-1
Package Description
1 VIAL, GLASS in 1 CARTON / 1 mg in 1 VIAL, GLASS
Product Code
73372-0116
11-Digit Billing Format
73372011601
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
Scenesse
Non-Proprietary Name
Afamelanotide
Substance Name
Afamelanotide
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
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
AFAMELANOTIDE 16 mg/16mg
Usage Information
SCENESSE® is indicated to increase pain free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP).

Regulatory & Marketing

Labeler Name
Clinuvel Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA210797
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-31-2019
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J7352
Source: OPPS
Afamelanotide implant, 1 mg
HCPCS Dosage 1 MG
Units / Pkg 16

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 73372-0116-1 identifies a specific commercial package of 1 vial, glass in 1 carton / 1 mg in 1 vial, glass of Scenesse, a human prescription drug labeled by Clinuvel 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 subcutaneous use and contains afamelanotide 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 Clinuvel Inc. on December 31, 2019. The current certification is valid through December 31, 2027.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 73372011601. 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)
73372-0116-1
11-Digit CMS (5-4-2)
73372-0116-01

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