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  4. NDC Product Code: 64011-701 Vyleesi

NDC 64011-701 Vyleesi

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 64011-701?
  4. Vyleesi Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Get all the details for National Drug Code (NDC) 64011-701 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
64011-701
Proprietary Name:
Vyleesi
Product Type: [3]
Labeler Name: [5]
Amag Pharmaceuticals, Inc.
Labeler Code:
64011
Product Label ID:
9146ae05-918b-483e-b86d-933485ce36eb
FDA Application Number: [6]
NDA210557
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date: [9]
06-21-2019
End Marketing Date: [10]
12-30-2024
Listing Expiration Date: [11]
12-30-2024
Exclude Flag: [12]
D
Code Navigator:

Code Structure Chart

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:

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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.
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Product Footnotes

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

[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

[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.

[10] What is the End Marketing Date? - This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

[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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".