Vyleesi Injection
NDC Package 80064-141-04

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

Package Information

Vyleesi (bremelanotide) injection is vYLEESI is indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD), as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is NOT due to: A co-existing medical or psychiatric condition, Problems with the relationship, or The effects of a medication or drug substance. This formulation utilizes a injection delivery system. Marketed by Palatin Technologies, this product is identified by NDC 80064-141 and is authorized under FDA application NDA210557.

Identification & Billing

NDC Package Code
80064-141-04
Package Description
4 SYRINGE in 1 CARTON / .3 mL in 1 SYRINGE (80064-141-01)
Product Code
80064-141
11-Digit Billing Format
80064014104
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 2176316 - bremelanotide 1.75 MG in 0.3 mL Auto-Injector
  • RxCUI: 2176316 - 0.3 ML bremelanotide 5.83 MG/ML Auto-Injector
  • RxCUI: 2176316 - bremelanotide 1.75 MG (equivalent to bremelanotide acetate 1.89 MG) per 0.3 ML Auto-Injector
  • RxCUI: 2176321 - vyleesi 1.75 MG in 0.3 mL Auto-Injector
  • RxCUI: 2176321 - 0.3 ML bremelanotide 5.83 MG/ML Auto-Injector [Vyleesi]

Clinical Specifications

Proprietary Name
Vyleesi
Non-Proprietary Name
Bremelanotide
Substance Name
Bremelanotide Acetate
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
BREMELANOTIDE ACETATE 1.75 mg/.3mL
Pharmacologic Class
Usage Information
VYLEESI is indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD), as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is NOT due to: A co-existing medical or psychiatric condition, Problems with the relationship, or The effects of a medication or drug substance. Acquired HSDD refers to HSDD that develops in a patient who previously had no problems with sexual desire. Generalized HSDD refers to HSDD that occurs regardless of the type of stimulation, situation or partner. Limitations of UseVYLEESI is not indicated for the treatment of HSDD in postmenopausal women or in men. VYLEESI is not indicated to enhance sexual performance.

Regulatory & Marketing

Labeler Name
Palatin Technologies
Product Type
Human Prescription Drug
FDA Application #
NDA210557
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-21-2019
End Marketing Date
07-01-2026
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (80064-141). Click a package code to view its specific billing and regulatory data.

80064-141-02
2 SYRINGE in 1 CARTON / .3 mL in 1 SYRINGE (80064-141-01)

* 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 80064-141-04 identifies a specific commercial package of 4 syringe in 1 carton / .3 ml in 1 syringe (80064-141-01) of Vyleesi, a human prescription drug labeled by Palatin Technologies. This injection is formulated for subcutaneous use and contains bremelanotide acetate 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 Palatin Technologies on June 21, 2019.

How is this Palatin Technologies product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80064014104. 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)
80064-141-04
11-Digit CMS (5-4-2)
80064-0141-04

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