65757-500

Generic: aripiprazole lauroxil

Labeler: alkermes, inc.
NDC Directory DRUG FOR FURTHER PROCESSING DRUG FOR FURTHER PROCESSING Active

Drug Facts

Product Profile

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

aripiprazole lauroxil 675 mg/2.4mL

Identifiers & Regulatory

Product NDC 65757-500
Product ID 65757-500_23c1899e-3c24-4b33-a032-3e69cb7c3f6c
Product Type DRUG FOR FURTHER PROCESSING
Marketing Category DRUG FOR FURTHER PROCESSING
Listing Expiration 2026-12-31
Marketing Start 2018-06-29

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65757500
Hyphenated Format 65757-500

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: label)
Generic Name aripiprazole lauroxil (source: ndc)
Application Number NDA209830 (source: label)
Routes
intramuscular
source: label

Resolved Composition

Strengths
  • 675 mg/2.4mL
source: ndc
Packaging
  • 20 TRAY in 1 CARTON (65757-500-00) / 15 SYRINGE in 1 TRAY / 2.4 mL in 1 SYRINGE
source: ndc

Packages (1)

65757-500-00 20 TRAY in 1 CARTON (65757-500-00) / 15 SYRINGE in 1 TRAY / 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 
{"spl_id": "23c1899e-3c24-4b33-a032-3e69cb7c3f6c", "openfda": {}, "finished": false, "packaging": [{"description": "20 TRAY in 1 CARTON (65757-500-00)  / 15 SYRINGE in 1 TRAY / 2.4 mL in 1 SYRINGE", "package_ndc": "65757-500-00", "marketing_start_date": "29-JUN-18"}], "product_id": "65757-500_23c1899e-3c24-4b33-a032-3e69cb7c3f6c", "dosage_form": "INJECTION, SUSPENSION, EXTENDED RELEASE", "product_ndc": "65757-500", "generic_name": "aripiprazole lauroxil", "labeler_name": "Alkermes, Inc.", "product_type": "DRUG FOR FURTHER PROCESSING", "brand_name_base": null, "active_ingredients": [{"name": "ARIPIPRAZOLE LAUROXIL", "strength": "675 mg/2.4mL"}], "marketing_category": "DRUG FOR FURTHER PROCESSING", "marketing_start_date": "20180629", "listing_expiration_date": "20261231"}