ganirelix acetate

Generic: ganirelix acetate

Labeler: lupin pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

ganirelix acetate 250 ug/.5mL

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 70748-274
Product ID 70748-274_c0fdd470-a16f-41c4-9bfa-4240b6ff67e7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216075
Listing Expiration 2026-12-31
Marketing Start 2024-02-14

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 70748274
Hyphenated Format 70748-274

Supplemental Identifiers

RxCUI
855200
UPC
0370748274019
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 ANDA216075 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 250 ug/.5mL
source: ndc
Packaging
  • 1 TRAY in 1 CARTON (70748-274-01) / 1 SYRINGE, GLASS in 1 TRAY / 1 mL in 1 SYRINGE, GLASS
source: ndc

Packages (1)

70748-274-01 1 TRAY in 1 CARTON (70748-274-01) / 1 SYRINGE, GLASS in 1 TRAY / 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": "c0fdd470-a16f-41c4-9bfa-4240b6ff67e7", "openfda": {"upc": ["0370748274019"], "unii": ["56U7906FQW"], "rxcui": ["855200"], "spl_set_id": ["e50888ef-5e66-4b15-bdc3-2f6794f09246"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TRAY in 1 CARTON (70748-274-01)  / 1 SYRINGE, GLASS in 1 TRAY / 1 mL in 1 SYRINGE, GLASS", "package_ndc": "70748-274-01", "marketing_start_date": "20240214"}], "brand_name": "Ganirelix Acetate", "product_id": "70748-274_c0fdd470-a16f-41c4-9bfa-4240b6ff67e7", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Decreased GnRH Secretion [PE]", "Gonadotropin Releasing Hormone Receptor Antagonist [EPC]", "Gonadotropin Releasing Hormone Receptor Antagonists [MoA]"], "product_ndc": "70748-274", "generic_name": "Ganirelix Acetate", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ganirelix Acetate", "active_ingredients": [{"name": "GANIRELIX ACETATE", "strength": "250 ug/.5mL"}], "application_number": "ANDA216075", "marketing_category": "ANDA", "marketing_start_date": "20240214", "listing_expiration_date": "20261231"}