ganirelix acetate

Generic: ganirelix acetate

Labeler: mullan pharmaceutical inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ganirelix acetate
Generic Name ganirelix acetate
Labeler mullan pharmaceutical inc.
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

ganirelix acetate 250 ug/.5mL

Manufacturer
Mullan Pharmaceutical Inc.

Identifiers & Regulatory

Product NDC 83301-0082
Product ID 83301-0082_23eef257-3b64-4b4a-80da-9cc557863b04
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218855
Listing Expiration 2027-12-31
Marketing Start 2026-01-13

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 833010082
Hyphenated Format 83301-0082

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 ANDA218855 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 250 ug/.5mL
source: ndc
Packaging
  • 1 SYRINGE, GLASS in 1 CARTON (83301-0082-1) / .5 mL in 1 SYRINGE, GLASS
source: ndc

Packages (1)

83301-0082-1 1 SYRINGE, GLASS in 1 CARTON (83301-0082-1) / .5 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": "23eef257-3b64-4b4a-80da-9cc557863b04", "openfda": {"unii": ["56U7906FQW"], "rxcui": ["855200"], "spl_set_id": ["420ce739-2756-4fb4-8a4e-5fab501ab973"], "manufacturer_name": ["Mullan Pharmaceutical Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE, GLASS in 1 CARTON (83301-0082-1)  / .5 mL in 1 SYRINGE, GLASS", "package_ndc": "83301-0082-1", "marketing_start_date": "20260113"}], "brand_name": "Ganirelix Acetate", "product_id": "83301-0082_23eef257-3b64-4b4a-80da-9cc557863b04", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Decreased GnRH Secretion [PE]", "Gonadotropin Releasing Hormone Receptor Antagonist [EPC]", "Gonadotropin Releasing Hormone Receptor Antagonists [MoA]"], "product_ndc": "83301-0082", "generic_name": "Ganirelix Acetate", "labeler_name": "Mullan Pharmaceutical Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ganirelix Acetate", "active_ingredients": [{"name": "GANIRELIX ACETATE", "strength": "250 ug/.5mL"}], "application_number": "ANDA218855", "marketing_category": "ANDA", "marketing_start_date": "20260113", "listing_expiration_date": "20271231"}