aristada

Generic: aripiprazole lauroxil

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

Drug Facts

Product Profile

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

aripiprazole lauroxil 882 mg/3.2mL

Manufacturer
Alkermes, Inc.

Identifiers & Regulatory

Product NDC 65757-403
Product ID 65757-403_3d951a36-1e73-4f84-8ebf-4d556d81a086
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA207533
Listing Expiration 2026-12-31
Marketing Start 2015-10-05

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65757403
Hyphenated Format 65757-403

Supplemental Identifiers

RxCUI
1673269 1673274 1673277 1673278 1673279 1673280 1925262 1925264
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 (source: ndc)
Generic Name aripiprazole lauroxil (source: ndc)
Application Number NDA207533 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 882 mg/3.2mL
source: ndc
Packaging
  • 1 SYRINGE in 1 CARTON (65757-403-03) / 3.2 mL in 1 SYRINGE
  • 1 SYRINGE in 1 CARTON (65757-403-04) / 3.2 mL in 1 SYRINGE
source: ndc

Packages (2)

65757-403-03 1 SYRINGE in 1 CARTON (65757-403-03) / 3.2 mL in 1 SYRINGE 65757-403-04 1 SYRINGE in 1 CARTON (65757-403-04) / 3.2 mL in 1 SYRINGE

Ingredients (1)

aripiprazole lauroxil (882 mg/3.2mL)

Linked Drug Pages (1)

ARISTADA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR"], "spl_id": "3d951a36-1e73-4f84-8ebf-4d556d81a086", "openfda": {"unii": ["B786J7A343"], "rxcui": ["1673269", "1673274", "1673277", "1673278", "1673279", "1673280", "1925262", "1925264"], "spl_set_id": ["17a8d11b-73b0-4833-a0b4-cf1ef85edefb"], "manufacturer_name": ["Alkermes, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE in 1 CARTON (65757-403-03)  / 3.2 mL in 1 SYRINGE", "package_ndc": "65757-403-03", "marketing_start_date": "20151005"}, {"sample": true, "description": "1 SYRINGE in 1 CARTON (65757-403-04)  / 3.2 mL in 1 SYRINGE", "package_ndc": "65757-403-04", "marketing_start_date": "20151005"}], "brand_name": "ARISTADA", "product_id": "65757-403_3d951a36-1e73-4f84-8ebf-4d556d81a086", "dosage_form": "INJECTION, SUSPENSION, EXTENDED RELEASE", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "65757-403", "generic_name": "aripiprazole lauroxil", "labeler_name": "Alkermes, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ARISTADA", "active_ingredients": [{"name": "ARIPIPRAZOLE LAUROXIL", "strength": "882 mg/3.2mL"}], "application_number": "NDA207533", "marketing_category": "NDA", "marketing_start_date": "20151005", "listing_expiration_date": "20261231"}