Package 83831-134-01

Brand: lutrate depot

Generic: leuprolide acetate
NDC Package

Package Facts

Identity

Package NDC 83831-134-01
Digits Only 8383113401
Product NDC 83831-134
Product ID 83831-134_d4332d30-8a83-4118-88bb-3c49851837b6
Description

1 KIT in 1 CARTON (83831-134-01) * 2 mL in 1 VIAL, SINGLE-DOSE (83831-150-22) * 2 mL in 1 SYRINGE (83831-135-02)

Marketing

Marketing Status
Marketed Since 2025-03-26
Brand lutrate depot
Generic leuprolide acetate
Sample Package No

Linked Drug Pages (1)

LUTRATE DEPOT ndc-match (0.95)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "d4332d30-8a83-4118-88bb-3c49851837b6", "openfda": {"rxcui": ["2606516", "2709448"], "spl_set_id": ["3a6d1373-17d9-4289-b62f-d299ffe55831"], "manufacturer_name": ["Avyxa Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (83831-134-01)  *  2 mL in 1 VIAL, SINGLE-DOSE (83831-150-22)  *  2 mL in 1 SYRINGE (83831-135-02)", "package_ndc": "83831-134-01", "marketing_start_date": "20250326"}], "brand_name": "LUTRATE DEPOT", "product_id": "83831-134_d4332d30-8a83-4118-88bb-3c49851837b6", "dosage_form": "KIT", "product_ndc": "83831-134", "generic_name": "leuprolide acetate", "labeler_name": "Avyxa Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LUTRATE DEPOT", "application_number": "NDA205054", "marketing_category": "NDA", "marketing_start_date": "20250326", "listing_expiration_date": "20261231"}