ganirelix acetate

Generic: ganirelix acetate

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ganirelix acetate
Generic Name ganirelix acetate
Labeler gland pharma limited
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

ganirelix acetate 250 ug/.5mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-472
Product ID 68083-472_9d647fa7-adc3-4767-a8e5-1b44b07cdd34
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215658
Listing Expiration 2026-12-31
Marketing Start 2023-02-28

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 68083472
Hyphenated Format 68083-472

Supplemental Identifiers

RxCUI
855200
UPC
0368083472016
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 BLISTER PACK in 1 CARTON (68083-472-01) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS
source: ndc

Packages (1)

68083-472-01 1 BLISTER PACK in 1 CARTON (68083-472-01) / 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": "9d647fa7-adc3-4767-a8e5-1b44b07cdd34", "openfda": {"upc": ["0368083472016"], "unii": ["56U7906FQW"], "rxcui": ["855200"], "spl_set_id": ["cad7c09c-234b-4e73-b460-a1b1f7adc28d"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (68083-472-01)  / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS", "package_ndc": "68083-472-01", "marketing_start_date": "20230228"}], "brand_name": "GANIRELIX ACETATE", "product_id": "68083-472_9d647fa7-adc3-4767-a8e5-1b44b07cdd34", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Decreased GnRH Secretion [PE]", "Gonadotropin Releasing Hormone Receptor Antagonist [EPC]", "Gonadotropin Releasing Hormone Receptor Antagonists [MoA]"], "product_ndc": "68083-472", "generic_name": "GANIRELIX ACETATE", "labeler_name": "Gland Pharma Limited", "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": "20230228", "listing_expiration_date": "20261231"}