NDC 0052-0301

Ganirelix Acetate

Ganirelix Acetate

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

Product ID0052-0301_21680ef9-07e9-4350-8f1b-51232fc3f0e1
NDC0052-0301
Product TypeHuman Prescription Drug
Proprietary NameGanirelix Acetate
Generic NameGanirelix Acetate
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date1999-07-29
Marketing CategoryNDA / NDA
Application NumberNDA021057
Labeler NameOrganon USA 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 Through2022-12-31

Packaging

NDC 0052-0301-51

1 BLISTER PACK in 1 CARTON (0052-0301-51) > 1 SYRINGE, GLASS in 1 BLISTER PACK > 1 mL in 1 SYRINGE, GLASS
Marketing Start Date1999-07-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0052-0301-81 [00052030181]

Ganirelix Acetate INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA021057
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1999-07-29

NDC 0052-0301-51 [00052030151]

Ganirelix Acetate INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA021057
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1999-07-29

Drug Details

Active Ingredients

IngredientStrength
GANIRELIX ACETATE250 ug/.5mL

OpenFDA Data

SPL SET ID:96118395-557e-4998-842d-424a59d574b6
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]
    • 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
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.