Vyleesi
These highlights do not include all the information needed to use VYLEESI™ safely and effectively. See full prescribing information for VYLEESI™. VYLEESI (bremelanotide injection), for subcutaneous use Initial U.S. Approval: 2019
Approved
Approval ID
9146ae05-918b-483e-b86d-933485ce36eb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 12, 2021
Manufacturers
FDA
AMAG Pharmaceuticals, Inc.
DUNS: 017511155
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
bremelanotide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64011-701
Application NumberNDA210557
Product Classification
M
Marketing Category
C73594
G
Generic Name
bremelanotide
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateSeptember 10, 2019
FDA Product Classification
INGREDIENTS (5)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BREMELANOTIDE ACETATEActive
Quantity: 1.75 mg in 0.3 mL
Code: PV2WI7495P
Classification: ACTIM
GLYCERINInactive
Quantity: 7.5 mg in 0.3 mL
Code: PDC6A3C0OX
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT