ABILIFY

Orange BookUNIISPLATC N05AX12

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

Identification

ManufacturerOtsuka America Pharmaceutical, Inc.

CountryUS (United States)

ATC codeN05AX12

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
5914800613
30 TABLET in 1 BOTTLE, PLASTIC (59148-006-13)
ndc11
5914800692
7 TABLET in 1 BLISTER PACK (59148-006-92)

Annotations

UNII (FDA Substance ID)

82VFR53I78

ARIPIPRAZOLE

RxCUI 89013

Orange Book

N021436

ABABABABABAB

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": "ORAL",
  "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": "59148-006_1b189d15-798d-4bed-a93d-a543ed7abd81",
  "productndc": "59148-006",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "021436",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Nov 15, 2002"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "15MG",
        "product_no": "002",
        "approval_date": "Nov 15, 2002"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "003",
        "approval_date": "Nov 15, 2002"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "30MG",
        "product_no": "004",
        "approval_date": "Nov 15, 2002"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "005",
        "approval_date": "Nov 15, 2002"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "006",
        "approval_date": "Nov 15, 2002"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ARIPIPRAZOLE",
  "proprietary_name": "ABILIFY",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021436",
  "marketing_category": "NDA",
  "nonproprietary_name": "ARIPIPRAZOLE",
  "start_marketing_date": "20021115",
  "active_numerator_strength": "2"
}

Related drugs

Other records sharing ATC code N05AX12.

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