NDC 0548-5001

Ganirelix Acetate

Ganirelix Acetate

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

Product ID0548-5001_0e71b74d-723d-46a4-b2e5-7c7157949ad4
NDC0548-5001
Product TypeHuman Prescription Drug
Proprietary NameGanirelix Acetate
Generic NameGanirelix Acetate
Dosage FormInjection
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2022-06-20
Marketing CategoryANDA /
Application NumberANDA212613
Labeler NameAmphastar Pharmaceuticals, Inc.
Substance NameGANIRELIX ACETATE
Active Ingredient Strength250 ug/.5mL
Pharm ClassesDecreased GnRH Secretion [PE], Gonadotropin Releasing Hormone Receptor Antagonist [EPC], Gonadotropin Releasing Hormone Receptor Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0548-5001-00

1 SYRINGE in 1 CARTON (0548-5001-00) > .5 mL in 1 SYRINGE
Marketing Start Date2022-06-20
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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