Aripiprazole

Orange BookUNIISPLATC N05AX12

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

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeN05AX12

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
7133518321
30 TABLET in 1 BOTTLE (71335-1832-1)
ndc11
7133518322
28 TABLET in 1 BOTTLE (71335-1832-2)
ndc11
7133518323
90 TABLET in 1 BOTTLE (71335-1832-3)
ndc11
7133518324
60 TABLET in 1 BOTTLE (71335-1832-4)
ndc11
7133518325
120 TABLET in 1 BOTTLE (71335-1832-5)
ndc11
7133518326
15 TABLET in 1 BOTTLE (71335-1832-6)

Annotations

UNII (FDA Substance ID)

82VFR53I78

ARIPIPRAZOLE

RxCUI 89013

Orange Book

A207105

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": "71335-1832_f43ca26f-40f6-45da-a0b1-1ee42eee6962",
  "productndc": "71335-1832",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "207105",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "001",
        "approval_date": "Feb 21, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "Feb 21, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "003",
        "approval_date": "Feb 21, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "15MG",
        "product_no": "004",
        "approval_date": "Feb 21, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "005",
        "approval_date": "Feb 21, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "30MG",
        "product_no": "006",
        "approval_date": "Feb 21, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ARIPIPRAZOLE",
  "proprietary_name": "Aripiprazole",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA207105",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Aripiprazole",
  "start_marketing_date": "20190227",
  "active_numerator_strength": "5"
}

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