Imcivree Solution
NDC Package 72829-010-01

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

Package Information

Imcivree (setmelanotide) solution is iMCIVREE is indicated for chronic weight management in adult and pediatric patients 6 years of age and older with obesity due to proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency confirmed by genetic testing demonstrating variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS). This formulation utilizes a solution delivery system. Marketed by Rhythm Pharmaceuticals, Inc, this product is identified by NDC 72829-010 and is authorized under FDA application NDA213793.

Identification & Billing

NDC Package Code
72829-010-01
Package Description
1 VIAL, MULTI-DOSE in 1 CARTON / 1 mL in 1 VIAL, MULTI-DOSE
Product Code
72829-010
11-Digit Billing Format
72829001001
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 2469346 - setmelanotide 10 MG/ML Injectable Solution
  • RxCUI: 2469346 - setmelanotide 10 MG/ML (as setmelanotide acetate) Injectable Solution
  • RxCUI: 2469351 - IMCIVREE 10 MG/ML Injectable Solution
  • RxCUI: 2469351 - setmelanotide 10 MG/ML Injectable Solution [Imcivree]
  • RxCUI: 2469351 - Imcivree 10 MG/ML (as setmelanotide acetate) Injectable Solution

Clinical Specifications

Proprietary Name
Imcivree
Non-Proprietary Name
Setmelanotide
Substance Name
Setmelanotide
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
SETMELANOTIDE 10 mg/mL
Pharmacologic Class
Usage Information
IMCIVREE is indicated for chronic weight management in adult and pediatric patients 6 years of age and older with obesity due to proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency confirmed by genetic testing demonstrating variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS). Limitations of Use: IMCIVREE is not indicated for the treatment of patients with the following conditions as IMCIVREE would not be expected to be effective: Obesity due to suspected POMC, PCSK1, or LEPR deficiency with POMC, PCSK1, or LEPR variants classified as benign or likely benignOther types of obesity not related to POMC, PCSK1 or LEPR deficiency, including obesity associated with other genetic syndromes and general (polygenic) obesity

Regulatory & Marketing

Labeler Name
Rhythm Pharmaceuticals, Inc
Product Type
Human Prescription Drug
FDA Application #
NDA213793
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-14-2020
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 72829-010-01 identifies a specific commercial package of 1 vial, multi-dose in 1 carton / 1 ml in 1 vial, multi-dose of Imcivree, a human prescription drug labeled by Rhythm Pharmaceuticals, Inc. This solution is formulated for subcutaneous use and contains setmelanotide 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 Rhythm Pharmaceuticals, Inc on December 14, 2020. The current certification is valid through December 31, 2027.

How is this Rhythm Pharmaceuticals, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72829001001. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
72829-010-01
11-Digit CMS (5-4-2)
72829-0010-01

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