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United States · US · US:62135-904_3540f59e-f085-8760-e063-6394a90aae82

Aripiprazole

Orange BookUNIISPLATC N05AX12

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

Identification

ManufacturerChartwell RX, LLC
CountryUS (United States)
ATC codeN05AX12
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6213590451
    150 mL in 1 BOTTLE (62135-904-51)

Annotations

UNII (FDA Substance ID)
82VFR53I78
ARIPIPRAZOLE
RxCUI 89013
Orange Book
A215595
AA
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": "62135-904_3540f59e-f085-8760-e063-6394a90aae82",
  "productndc": "62135-904",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "215595",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "1MG/ML",
        "product_no": "001",
        "approval_date": "Oct 25, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ARIPIPRAZOLE",
  "proprietary_name": "Aripiprazole",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA215595",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Aripiprazole",
  "start_marketing_date": "20221025",
  "active_numerator_strength": "1"
}

Related drugs

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