Package 83634-454-61

Brand: leuprolide acetate

Generic: leuprolide acetate
NDC Package

Package Facts

Identity

Package NDC 83634-454-61
Digits Only 8363445461
Product NDC 83634-454
Description

1 KIT in 1 CARTON (83634-454-61) * 1 mL in 1 PACKET (83634-453-01) * 2.8 mL in 1 VIAL, MULTI-DOSE (83634-452-03)

Marketing

Marketing Status
Marketed Since 2025-03-15
Brand leuprolide acetate
Generic leuprolide acetate
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["SUBCUTANEOUS"], "spl_id": "92eaabb9-7dde-4153-9794-fa0f0b72b05f", "openfda": {"rxcui": ["545835", "797544"], "spl_set_id": ["15003c37-6e91-4c79-a85c-3d03343b53f9"], "manufacturer_name": ["Avenacy Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (83634-454-61)  *  1 mL in 1 PACKET (83634-453-01)  *  2.8 mL in 1 VIAL, MULTI-DOSE (83634-452-03)", "package_ndc": "83634-454-61", "marketing_start_date": "20250315"}], "brand_name": "Leuprolide Acetate", "product_id": "83634-454_92eaabb9-7dde-4153-9794-fa0f0b72b05f", "dosage_form": "KIT", "product_ndc": "83634-454", "generic_name": "leuprolide acetate", "labeler_name": "Avenacy Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Leuprolide Acetate", "application_number": "ANDA217957", "marketing_category": "ANDA", "marketing_start_date": "20250315", "listing_expiration_date": "20261231"}