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United States · US · US:59148-102_284a898a-06c2-4ef9-9cb9-5d3e6cf94f9c

Abilify Asimtufii

Orange BookUNIISPLATC N05AX12

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerOtsuka America Pharmaceutical, Inc
CountryUS (United States)
ATC codeN05AX12
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5914810280
    1 SYRINGE in 1 CARTON (59148-102-80) / 2.4 mL in 1 SYRINGE

Annotations

UNII (FDA Substance ID)
82VFR53I78
ARIPIPRAZOLE
RxCUI 89013
Orange Book
N217006
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "82VFR53I78",
    "rxcui": "89013",
    "inchikey": "CEUORZQYGODEFX-UHFFFAOYSA-N",
    "display_name": "ARIPIPRAZOLE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR",
  "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": "59148-102_284a898a-06c2-4ef9-9cb9-5d3e6cf94f9c",
  "productndc": "59148-102",
  "dosage_form": "INJECTION, SUSPENSION, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "217006",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "720MG/2.4ML (300MG/ML)",
        "product_no": "001",
        "approval_date": "Apr 27, 2023"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "960MG/3.2ML (300MG/ML)",
        "product_no": "002",
        "approval_date": "Apr 27, 2023"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ARIPIPRAZOLE",
  "proprietary_name": "Abilify Asimtufii",
  "active_ingred_unit": "mg/2.4mL",
  "application_number": "NDA217006",
  "marketing_category": "NDA",
  "nonproprietary_name": "Aripiprazole",
  "start_marketing_date": "20230427",
  "active_numerator_strength": "720"
}

Related drugs

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