ganirelix acetate

Generic: ganirelix acetate

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

Drug Facts

Product Profile

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

ganirelix acetate 250 ug/.5mL

Manufacturer
Amphastar Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0548-5001
Product ID 0548-5001_0e71b74d-723d-46a4-b2e5-7c7157949ad4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212613
Listing Expiration 2026-12-31
Marketing Start 2022-06-20

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 05485001
Hyphenated Format 0548-5001

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 ANDA212613 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 250 ug/.5mL
source: ndc
Packaging
  • 1 SYRINGE in 1 CARTON (0548-5001-00) / .5 mL in 1 SYRINGE
source: ndc

Packages (1)

0548-5001-00 1 SYRINGE in 1 CARTON (0548-5001-00) / .5 mL in 1 SYRINGE

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": "0e71b74d-723d-46a4-b2e5-7c7157949ad4", "openfda": {"unii": ["56U7906FQW"], "rxcui": ["855200"], "spl_set_id": ["9c286f64-8039-44ec-8fdd-d1a2f52b4c3c"], "manufacturer_name": ["Amphastar Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE in 1 CARTON (0548-5001-00)  / .5 mL in 1 SYRINGE", "package_ndc": "0548-5001-00", "marketing_start_date": "20220620"}], "brand_name": "Ganirelix Acetate", "product_id": "0548-5001_0e71b74d-723d-46a4-b2e5-7c7157949ad4", "dosage_form": "INJECTION", "pharm_class": ["Decreased GnRH Secretion [PE]", "Gonadotropin Releasing Hormone Receptor Antagonist [EPC]", "Gonadotropin Releasing Hormone Receptor Antagonists [MoA]"], "product_ndc": "0548-5001", "generic_name": "Ganirelix Acetate", "labeler_name": "Amphastar Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ganirelix Acetate", "active_ingredients": [{"name": "GANIRELIX ACETATE", "strength": "250 ug/.5mL"}], "application_number": "ANDA212613", "marketing_category": "ANDA", "marketing_start_date": "20220620", "listing_expiration_date": "20261231"}