Ganirelix Acetate
Ganirelix Acetate Injection
Approved
Approval ID
c23ca7b2-7350-4f07-8adf-046bffb47842
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 14, 2023
Manufacturers
FDA
Fresenius Kabi USA, LLC
DUNS: 013547657
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ganirelix Acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65219-028
Application NumberANDA215658
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ganirelix Acetate
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateFebruary 1, 2023
FDA Product Classification
INGREDIENTS (5)
mannitolInactive
Quantity: 23.5 mg in 0.5 mL
Code: 3OWL53L36A
Classification: IACT
Ganirelix AcetateActive
Quantity: 250 ug in 0.5 mL
Code: 56U7906FQW
Classification: ACTIB
waterInactive
Code: 059QF0KO0R
Classification: IACT
acetic acidInactive
Quantity: 0.1 mg in 0.5 mL
Code: Q40Q9N063P
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT