Back to search
🇺🇸

United States · US · US:65162-893_d6606ae3-90c2-4332-ab9f-da0b1c593c88

Aripiprazole

Orange BookUNIISPLATC N05AX12

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

Identification

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

Packs · 1

  • ndc11
    6516289374
    1 BOTTLE in 1 CARTON (65162-893-74) / 150 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
82VFR53I78
ARIPIPRAZOLE
RxCUI 89013
Orange Book
A203906
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": "65162-893_d6606ae3-90c2-4332-ab9f-da0b1c593c88",
  "productndc": "65162-893",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "203906",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AA",
        "strength": "1MG/ML",
        "product_no": "001",
        "approval_date": "Aug 14, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ARIPIPRAZOLE",
  "proprietary_name": "Aripiprazole",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA203906",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Aripiprazole",
  "start_marketing_date": "20150817",
  "active_numerator_strength": "1"
}

Related drugs

Other records sharing ATC code N05AX12.

Access this data programmatically

Query Aripiprazole and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.