aripiprazole

Orange BookUNIISPLATC N05AX12

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

Identification

ManufacturerTorrent Pharmaceuticals Limited

CountryUS (United States)

ATC codeN05AX12

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
1366821801
100 TABLET in 1 BOTTLE (13668-218-01)
ndc11
1366821805
500 TABLET in 1 BOTTLE (13668-218-05)
ndc11
1366821830
30 TABLET in 1 BOTTLE (13668-218-30)
ndc11
1366821852
7000 TABLET in 1 BOTTLE (13668-218-52)
ndc11
1366821890
90 TABLET in 1 BOTTLE (13668-218-90)

Annotations

UNII (FDA Substance ID)

82VFR53I78

ARIPIPRAZOLE

RxCUI 89013

Orange Book

A201519

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": "13668-218_264dc32a-9f5f-43be-96ee-0d30503de683",
  "productndc": "13668-218",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "201519",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "001",
        "approval_date": "Apr 28, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "Apr 28, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "003",
        "approval_date": "Apr 28, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "15MG",
        "product_no": "004",
        "approval_date": "Apr 28, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "005",
        "approval_date": "Apr 28, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "30MG",
        "product_no": "006",
        "approval_date": "Apr 28, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ARIPIPRAZOLE",
  "proprietary_name": "aripiprazole",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA201519",
  "marketing_category": "ANDA",
  "nonproprietary_name": "aripiprazole",
  "start_marketing_date": "20150428",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code N05AX12.

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