Package 65757-500-03

Brand: aristada initio

Generic: aripiprazole lauroxil
NDC Package

Package Facts

Identity

Package NDC 65757-500-03
Digits Only 6575750003
Product NDC 65757-500
Description

1 SYRINGE in 1 CARTON (65757-500-03) / 2.4 mL in 1 SYRINGE

Marketing

Marketing Status
Marketed Since 2018-06-29
Brand aristada initio
Generic aripiprazole lauroxil
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["INTRAMUSCULAR"], "spl_id": "cbde23b9-60d1-4ae1-b42d-1093610ba18d", "openfda": {"unii": ["B786J7A343"], "rxcui": ["2049341", "2049343"], "spl_set_id": ["b18fdfd9-31cd-4a2f-9f1c-ebc70d7a9403"], "manufacturer_name": ["Alkermes, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE in 1 CARTON (65757-500-03)  / 2.4 mL in 1 SYRINGE", "package_ndc": "65757-500-03", "marketing_start_date": "20180629"}, {"sample": true, "description": "1 SYRINGE in 1 CARTON (65757-500-04)  / 2.4 mL in 1 SYRINGE", "package_ndc": "65757-500-04", "marketing_start_date": "20180629"}], "brand_name": "ARISTADA INITIO", "product_id": "65757-500_cbde23b9-60d1-4ae1-b42d-1093610ba18d", "dosage_form": "INJECTION, SUSPENSION, EXTENDED RELEASE", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "65757-500", "generic_name": "aripiprazole lauroxil", "labeler_name": "Alkermes, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ARISTADA INITIO", "active_ingredients": [{"name": "ARIPIPRAZOLE LAUROXIL", "strength": "675 mg/2.4mL"}], "application_number": "NDA209830", "marketing_category": "NDA", "marketing_start_date": "20180629", "listing_expiration_date": "20261231"}