ABILIFY MAINTENA

Orange BookSPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerOtsuka America Pharmaceutical, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5914804580
1 KIT in 1 CARTON (59148-045-80) * 1.5 mL in 1 SYRINGE * 5 mL in 1 SYRINGE

Annotations

Orange Book

N202971

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "ee49f3b1-1650-47ff-9fb1-ea53fe0b92b6": {
      "match": "brand_token",
      "title": "ABILIFY MAINTENA (ARIPIPRAZOLE) KIT [OTSUKA AMERICA PHARMACEUTICAL, INC.]",
      "spl_version": "27",
      "published_date": "2026-03-30"
    }
  },
  "productid": "59148-045_30e40a02-9942-4914-8d84-cf5a8058cec6",
  "productndc": "59148-045",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "202971",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "300MG/VIAL",
        "product_no": "001",
        "approval_date": "Feb 28, 2013"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "400MG/VIAL",
        "product_no": "002",
        "approval_date": "Feb 28, 2013"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "300MG",
        "product_no": "003",
        "approval_date": "Sep 29, 2014"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "400MG",
        "product_no": "004",
        "approval_date": "Sep 29, 2014"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "ABILIFY MAINTENA",
  "active_ingred_unit": null,
  "application_number": "NDA202971",
  "marketing_category": "NDA",
  "nonproprietary_name": "aripiprazole",
  "start_marketing_date": "20141008",
  "active_numerator_strength": null
}

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