ILOPERIDONE

Orange BookUNIISPLATC N05AX14

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

Identification

ManufacturerMylan Pharmaceuticals Inc.

CountryUS (United States)

ATC codeN05AX14

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
0378063501
100 TABLET in 1 BOTTLE (0378-0635-01)
ndc11
0378063588
10 BLISTER PACK in 1 CARTON (0378-0635-88) / 10 TABLET in 1 BLISTER PACK
ndc11
0378063591
60 TABLET in 1 BOTTLE (0378-0635-91)

Annotations

UNII (FDA Substance ID)

VPO7KJ050N

ILOPERIDONE

RxCUI 73178

Orange Book

A207231

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "VPO7KJ050N",
    "rxcui": "73178",
    "inchikey": "XMXHEBAFVSFQEX-UHFFFAOYSA-N",
    "display_name": "ILOPERIDONE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "eeb0fcfd-e4e8-4fb1-9635-901dc9446235": {
      "match": "brand_token",
      "title": "ILOPERIDONE TABLET [MYLAN PHARMACEUTICALS INC.]",
      "spl_version": "10",
      "published_date": "2025-03-17"
    }
  },
  "productid": "0378-0635_30392c6b-2f42-6e82-e063-6394a90a0c88",
  "productndc": "0378-0635",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "207231",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "1MG",
        "product_no": "001",
        "approval_date": "Nov 28, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "2MG",
        "product_no": "002",
        "approval_date": "Nov 28, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "4MG",
        "product_no": "003",
        "approval_date": "Nov 28, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "6MG",
        "product_no": "004",
        "approval_date": "Nov 28, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "8MG",
        "product_no": "005",
        "approval_date": "Nov 28, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "006",
        "approval_date": "Nov 28, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "12MG",
        "product_no": "007",
        "approval_date": "Nov 28, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ILOPERIDONE",
  "proprietary_name": "ILOPERIDONE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA207231",
  "marketing_category": "ANDA",
  "nonproprietary_name": "iloperidone",
  "start_marketing_date": "20170320",
  "active_numerator_strength": "10"
}

Related drugs

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