ganirelix acetate

Generic: ganirelix acetate

Labeler: organon llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name ganirelix acetate
Generic Name ganirelix acetate
Labeler organon llc
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

ganirelix acetate 250 ug/.5mL

Manufacturer
Organon LLC

Identifiers & Regulatory

Product NDC 78206-138
Product ID 78206-138_8e2e2cd7-1d83-4f9f-85be-d047bf413f98
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021057
Listing Expiration 2026-12-31
Marketing Start 2021-06-01

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 78206138
Hyphenated Format 78206-138

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 NDA021057 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 250 ug/.5mL
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (78206-138-01) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS
  • 1 BLISTER PACK in 1 CARTON (78206-138-02) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS
source: ndc

Packages (2)

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 78206-138-02 1 BLISTER PACK in 1 CARTON (78206-138-02) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 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": "8e2e2cd7-1d83-4f9f-85be-d047bf413f98", "openfda": {"unii": ["56U7906FQW"], "rxcui": ["855200"], "spl_set_id": ["32fb74ff-993a-49fe-8943-e029372b863e"], "manufacturer_name": ["Organon LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (78206-138-01)  / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS", "package_ndc": "78206-138-01", "marketing_start_date": "20210601"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (78206-138-02)  / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS", "package_ndc": "78206-138-02", "marketing_start_date": "20240216"}], "brand_name": "Ganirelix Acetate", "product_id": "78206-138_8e2e2cd7-1d83-4f9f-85be-d047bf413f98", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Decreased GnRH Secretion [PE]", "Gonadotropin Releasing Hormone Receptor Antagonist [EPC]", "Gonadotropin Releasing Hormone Receptor Antagonists [MoA]"], "product_ndc": "78206-138", "generic_name": "Ganirelix Acetate", "labeler_name": "Organon LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ganirelix Acetate", "active_ingredients": [{"name": "GANIRELIX ACETATE", "strength": "250 ug/.5mL"}], "application_number": "NDA021057", "marketing_category": "NDA", "marketing_start_date": "20210601", "listing_expiration_date": "20261231"}