NDC 64011-701

Vyleesi

Bremelanotide

Vyleesi is a Subcutaneous Injection in the Human Prescription Drug category. It is labeled and distributed by Amag Pharmaceuticals, Inc.. The primary component is Bremelanotide Acetate.

Product ID64011-701_2fa95781-814b-4e03-a2c9-7b58734d5987
NDC64011-701
Product TypeHuman Prescription Drug
Proprietary NameVyleesi
Generic NameBremelanotide
Dosage FormInjection
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2019-06-21
Marketing CategoryNDA / NDA
Application NumberNDA210557
Labeler NameAMAG Pharmaceuticals, Inc.
Substance NameBREMELANOTIDE ACETATE
Active Ingredient Strength2 mg/.3mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 64011-701-04

4 SYRINGE in 1 CARTON (64011-701-04) > .3 mL in 1 SYRINGE (64011-701-01)
Marketing Start Date2019-06-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 64011-701-04 [64011070104]

Vyleesi INJECTION
Marketing CategoryNDA
Application NumberNDA210557
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-06-21

NDC 64011-701-12 [64011070112]

Vyleesi INJECTION
Marketing CategoryNDA
Application NumberNDA210557
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-09-09

NDC 64011-701-01 [64011070101]

Vyleesi INJECTION
Marketing CategoryNDA
Application NumberNDA210557
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-06-21

Drug Details

Active Ingredients

IngredientStrength
BREMELANOTIDE ACETATE1.75 mg/.3mL

OpenFDA Data

SPL SET ID:9146ae05-918b-483e-b86d-933485ce36eb
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2176316
  • 2176321
  • NDC Crossover Matching brand name "Vyleesi" or generic name "Bremelanotide"

    NDCBrand NameGeneric Name
    64011-701Vyleesibremelanotide
    80064-141Vyleesibremelanotide

    Trademark Results [Vyleesi]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    VYLEESI
    VYLEESI
    87665906 5897765 Live/Registered
    AMAG Pharmaceuticals, Inc.
    2017-10-31

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.