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United States · US · US:0615-8524_b4492067-a61a-4f62-a09a-ae26e8f35baa

Aripiprazole

Orange BookUNIISPLATC N05AX12

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

Identification

ManufacturerNCS HealthCare of KY, LLC dba Vangard Labs
CountryUS (United States)
ATC codeN05AX12
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0615852439
    30 TABLET in 1 BLISTER PACK (0615-8524-39)

Annotations

UNII (FDA Substance ID)
82VFR53I78
ARIPIPRAZOLE
RxCUI 89013
Orange Book
A206383
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": {
    "52cc86ba-2c4f-1aba-e063-6294a90a844e": {
      "match": "brand_token",
      "title": "ARIPIPRAZOLE TABLET [COUPLER LLC]",
      "spl_version": "1",
      "published_date": "2026-05-28"
    }
  },
  "productid": "0615-8524_b4492067-a61a-4f62-a09a-ae26e8f35baa",
  "productndc": "0615-8524",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "206383",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "001",
        "approval_date": "Sep 29, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "Sep 29, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "003",
        "approval_date": "Sep 29, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "15MG",
        "product_no": "004",
        "approval_date": "Sep 29, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "005",
        "approval_date": "Sep 29, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "30MG",
        "product_no": "006",
        "approval_date": "Sep 29, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ARIPIPRAZOLE",
  "proprietary_name": "Aripiprazole",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA206383",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Aripiprazole",
  "start_marketing_date": "20200316",
  "active_numerator_strength": "2"
}

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