NDC 55566-1000

Ganirelix Acetate

Ganirelix Acetate

Ganirelix Acetate is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Ferring Pharmaceuticals Inc.. The primary component is Ganirelix Acetate.

Product ID55566-1000_443a2d58-f4f2-4597-8cb0-14db3b050008
NDC55566-1000
Product TypeHuman Prescription Drug
Proprietary NameGanirelix Acetate
Generic NameGanirelix Acetate
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2019-01-01
Marketing CategoryANDA / ANDA
Application NumberANDA204246
Labeler NameFERRING PHARMACEUTICALS INC.
Substance NameGANIRELIX ACETATE
Active Ingredient Strength250 ug/.5mL
Pharm ClassesDecreased GnRH Secretion [PE],Gonadotropin Releasing Hormone Antagonist [EPC],Gonadotropin Releasing Hormone Receptor Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 55566-1000-1

1 BLISTER PACK in 1 CARTON (55566-1000-1) > 1 SYRINGE in 1 BLISTER PACK > .5 mL in 1 SYRINGE
Marketing Start Date2019-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55566-1000-1 [55566100001]

Ganirelix Acetate INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA204246
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-01-01

Drug Details

Active Ingredients

IngredientStrength
GANIRELIX ACETATE250 ug/.5mL

OpenFDA Data

SPL SET ID:d4e0bcb6-7c24-494b-a775-a1b23d1cdc71
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 855200

    • Pharmacological Class

    • Decreased GnRH Secretion [PE]
    • Gonadotropin Releasing Hormone Antagonist [EPC]
    • Gonadotropin Releasing Hormone Receptor Antagonists [MoA]

    NDC Crossover Matching brand name "Ganirelix Acetate" or generic name "Ganirelix Acetate"

    NDCBrand NameGeneric Name
    0052-0301Ganirelix AcetateGanirelix Acetate
    0548-5001Ganirelix AcetateGanirelix Acetate
    55566-1000Ganirelix AcetateGanirelix Acetate
    62756-072Ganirelix AcetateGanirelix Acetate
    71288-554Ganirelix AcetateGanirelix Acetate
    78206-138Ganirelix AcetateGanirelix Acetate
    55566-1010Fyremadelganirelix acetate
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.