aristada initio

Generic: aripiprazole lauroxil

Labeler: alkermes, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name aristada initio
Generic Name aripiprazole lauroxil
Labeler alkermes, inc.
Dosage Form INJECTION, SUSPENSION, EXTENDED RELEASE
Routes
INTRAMUSCULAR
Active Ingredients

aripiprazole lauroxil 675 mg/2.4mL

Manufacturer
Alkermes, Inc.

Identifiers & Regulatory

Product NDC 65757-500
Product ID 65757-500_cbde23b9-60d1-4ae1-b42d-1093610ba18d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA209830
Listing Expiration 2026-12-31
Marketing Start 2018-06-29

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65757500
Hyphenated Format 65757-500

Supplemental Identifiers

RxCUI
2049341 2049343
UNII
B786J7A343

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 aristada initio (source: ndc)
Generic Name aripiprazole lauroxil (source: ndc)
Application Number NDA209830 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 675 mg/2.4mL
source: ndc
Packaging
  • 1 SYRINGE in 1 CARTON (65757-500-03) / 2.4 mL in 1 SYRINGE
  • 1 SYRINGE in 1 CARTON (65757-500-04) / 2.4 mL in 1 SYRINGE
source: ndc

Packages (2)

65757-500-03 1 SYRINGE in 1 CARTON (65757-500-03) / 2.4 mL in 1 SYRINGE 65757-500-04 1 SYRINGE in 1 CARTON (65757-500-04) / 2.4 mL in 1 SYRINGE

Ingredients (1)

aripiprazole lauroxil (675 mg/2.4mL)

Linked Drug Pages (1)

ARISTADA INITIO ndc-match (0.9)

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"}