NDC Package 72829-010-01 Imcivree

Setmelanotide Solution Subcutaneous - View Billable Units, 11-Digit Format, RxNorm

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
72829-010-01
Package Description:
1 VIAL, MULTI-DOSE in 1 CARTON / 1 mL in 1 VIAL, MULTI-DOSE
Product Code:
Proprietary Name:
Imcivree
Non-Proprietary Name:
Setmelanotide
Substance Name:
Setmelanotide
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
11-Digit NDC Billing Format:
72829001001
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to 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
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Rhythm Pharmaceuticals, Inc
    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(s):
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
  • Active Ingredient(s):
    Sample Package:
    No
    FDA Application Number:
    NDA213793
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    12-14-2020
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 72829-010-01?

    The NDC Packaged Code 72829-010-01 is assigned to a 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. The product's dosage form is solution and is administered via subcutaneous form.

    Is NDC 72829-010 included in the NDC Directory?

    Yes, Imcivree with product code 72829-010 is active and included in the NDC Directory. The product was first marketed by Rhythm Pharmaceuticals, Inc on December 14, 2020 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 72829-010-01?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 72829-010-01?

    The 11-digit format is 72829001001. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-272829-010-015-4-272829-0010-01