ganirelix acetate

Generic: ganirelix acetate

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ganirelix acetate
Generic Name ganirelix acetate
Labeler fresenius kabi usa, llc
Dosage Form INJECTION
Routes
SUBCUTANEOUS
Active Ingredients

ganirelix acetate 250 ug/.5mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 65219-028
Product ID 65219-028_8b68715d-8b5a-473f-90fb-453ba4267b84
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215658
Listing Expiration 2026-12-31
Marketing Start 2023-03-24

Pharmacologic Class

Classes
decreased gnrh secretion [pe] gonadotropin releasing hormone receptor antagonist [epc] gonadotropin releasing hormone receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65219028
Hyphenated Format 65219-028

Supplemental Identifiers

RxCUI
855200
UNII
56U7906FQW

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name ganirelix acetate (source: ndc)
Generic Name ganirelix acetate (source: ndc)
Application Number ANDA215658 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 250 ug/.5mL
source: ndc
Packaging
  • 1 SYRINGE, GLASS in 1 CARTON (65219-028-05) / 1 mL in 1 SYRINGE, GLASS
source: ndc

Packages (1)

65219-028-05 1 SYRINGE, GLASS in 1 CARTON (65219-028-05) / 1 mL in 1 SYRINGE, GLASS

Ingredients (1)

ganirelix acetate (250 ug/.5mL)

Linked Drug Pages (1)

Ganirelix Acetate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "8b68715d-8b5a-473f-90fb-453ba4267b84", "openfda": {"unii": ["56U7906FQW"], "rxcui": ["855200"], "spl_set_id": ["c23ca7b2-7350-4f07-8adf-046bffb47842"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE, GLASS in 1 CARTON (65219-028-05)  / 1 mL in 1 SYRINGE, GLASS", "package_ndc": "65219-028-05", "marketing_start_date": "20230324"}], "brand_name": "Ganirelix Acetate", "product_id": "65219-028_8b68715d-8b5a-473f-90fb-453ba4267b84", "dosage_form": "INJECTION", "pharm_class": ["Decreased GnRH Secretion [PE]", "Gonadotropin Releasing Hormone Receptor Antagonist [EPC]", "Gonadotropin Releasing Hormone Receptor Antagonists [MoA]"], "product_ndc": "65219-028", "generic_name": "Ganirelix Acetate", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ganirelix Acetate", "active_ingredients": [{"name": "GANIRELIX ACETATE", "strength": "250 ug/.5mL"}], "application_number": "ANDA215658", "marketing_category": "ANDA", "marketing_start_date": "20230324", "listing_expiration_date": "20261231"}