Aripiprazole

Orange BookUNIISPLATC N05AX12

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

Identification

ManufacturerAlembic Pharmaceuticals Limited

CountryUS (United States)

ATC codeN05AX12

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 7

ndc11
4670825510
100 TABLET in 1 CARTON (46708-255-10)
ndc11
4670825530
30 TABLET in 1 BOTTLE (46708-255-30)
ndc11
4670825531
100 TABLET in 1 BOTTLE (46708-255-31)
ndc11
4670825545
180 TABLET in 1 BOTTLE (46708-255-45)
ndc11
4670825560
60 TABLET in 1 BOTTLE (46708-255-60)
ndc11
4670825571
500 TABLET in 1 BOTTLE (46708-255-71)
ndc11
4670825591
1000 TABLET in 1 BOTTLE (46708-255-91)

Annotations

UNII (FDA Substance ID)

82VFR53I78

ARIPIPRAZOLE

RxCUI 89013

Orange Book

A202101

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": "46708-255_5108607e-5633-4b19-82f9-6c48720960c4",
  "productndc": "46708-255",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "202101",
    "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": "ANDA202101",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Aripiprazole",
  "start_marketing_date": "20150428",
  "active_numerator_strength": "5"
}

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