NDC 78206-138

Ganirelix Acetate

Ganirelix Acetate

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

Product ID78206-138_31ce02aa-9418-460e-a146-06deb454ac98
NDC78206-138
Product TypeHuman Prescription Drug
Proprietary NameGanirelix Acetate
Generic NameGanirelix Acetate
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2021-06-01
Marketing CategoryNDA /
Application NumberNDA021057
Labeler NameOrganon LLC
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 78206-138-01

1 BLISTER PACK in 1 CARTON (78206-138-01) > 1 SYRINGE, GLASS in 1 BLISTER PACK > 1 mL in 1 SYRINGE, GLASS
Marketing Start Date2021-06-01
NDC Exclude FlagN
Sample Package?N

Drug Details

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

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