NDC 64011-701 Vyleesi

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
64011-701
Proprietary Name:
Vyleesi
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Amag Pharmaceuticals, Inc.
Labeler Code:
64011
Start Marketing Date: [9]
06-21-2019
Listing Expiration Date: [11]
12-31-2022
Exclude Flag: [12]
I
Code Navigator:

Product Packages

NDC Code 64011-701-04

Package Description: 4 SYRINGE in 1 CARTON / .3 mL in 1 SYRINGE (64011-701-01)

NDC Code 64011-701-12

Package Description: 2 SYRINGE in 1 CARTON / .3 mL in 1 SYRINGE (64011-701-01)

Product Details

What is NDC 64011-701?

The NDC code 64011-701 is assigned by the FDA to the product Vyleesi which is product labeled by Amag Pharmaceuticals, Inc.. The product's dosage form is . The product is distributed in 2 packages with assigned NDC codes 64011-701-04 4 syringe in 1 carton / .3 ml in 1 syringe (64011-701-01), 64011-701-12 2 syringe in 1 carton / .3 ml in 1 syringe (64011-701-01). This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Vyleesi?

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, orThe 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.

Which are Vyleesi UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Vyleesi Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Vyleesi?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • 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]

* Please review the disclaimer below.

Patient Education

Bremelanotide Injection


Bremelanotide injection is used to treat women with hypoactive sexual desire disorder (HSDD; a low sexual desire that causes distress or interpersonal difficulty) who have not experienced menopause (change of life; the end of monthly menstrual periods); who have not had problems with low sexual desire in the past; and whose low sexual desire is not due to a medical or mental health problem, a relationship problem, or medication or other drug use. Bremelanotide injection should not be used for the treatment of HSDD in women who have gone through menopause, in men, or to improve sexual performance. Bremelanotide injection is in a class of medications called melanocortin receptor agonists. It works by activating certain natural substances in the brain that control mood and thinking.
[Learn More]


* Please review the disclaimer below.

Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".