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 ID: 55566-1000_443a2d58-f4f2-4597-8cb0-14db3b050008
• NDC: 55566-1000
• Product Type: Human Prescription Drug
• Proprietary Name: Ganirelix Acetate
• Generic Name: Ganirelix Acetate
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2019-01-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA204246
• Labeler Name: FERRING PHARMACEUTICALS INC.
• Substance Name: GANIRELIX ACETATE
• Active Ingredient Strength: 250 ug/.5mL
• Pharm Classes: Decreased GnRH Secretion [PE],Gonadotropin Releasing Hormone Antagonist [EPC],Gonadotropin Releasing Hormone Receptor Antagonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

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 Date: 2019-01-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55566-1000-1 [55566100001]

Ganirelix Acetate INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA204246
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-01-01

Drug Details

Active Ingredients

Ingredient	Strength
GANIRELIX ACETATE	250 ug/.5mL

OpenFDA Data

• SPL SET ID: d4e0bcb6-7c24-494b-a775-a1b23d1cdc71
• Manufacturer:
  • FERRING PHARMACEUTICALS INC.
• UNII:
  • 56U7906FQW
• 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"

NDC	Brand Name	Generic Name
0052-0301	Ganirelix Acetate	Ganirelix Acetate
0548-5001	Ganirelix Acetate	Ganirelix Acetate
55566-1000	Ganirelix Acetate	Ganirelix Acetate
62756-072	Ganirelix Acetate	Ganirelix Acetate
71288-554	Ganirelix Acetate	Ganirelix Acetate
78206-138	Ganirelix Acetate	Ganirelix Acetate
55566-1010	Fyremadel	ganirelix acetate