RISPERDAL

Orange BookUNIISPLATC N05AX08

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

Identification

ManufacturerJanssen Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeN05AX08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
5045835001
10 BLISTER PACK in 1 BOX, UNIT-DOSE (50458-350-01) / 10 TABLET in 1 BLISTER PACK
ndc11
5045835006
60 TABLET in 1 BOTTLE (50458-350-06)

Annotations

UNII (FDA Substance ID)

L6UH7ZF8HC

RISPERIDONE

RxCUI 35636

Orange Book

N020272

ABABABABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "L6UH7ZF8HC",
    "rxcui": "35636",
    "inchikey": "RAPZEAPATHNIPO-UHFFFAOYSA-N",
    "display_name": "RISPERIDONE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "bb34ee82-d2c2-43b8-ba21-2825c0954691": {
      "match": "brand_token",
      "title": "RISPERDAL CONSTA (RISPERIDONE) KIT [JANSSEN PHARMACEUTICALS, INC.]",
      "spl_version": "38",
      "published_date": "2025-11-17"
    }
  },
  "productid": "50458-350_408e48a3-35fc-49e1-8e01-44305d9083a4",
  "productndc": "50458-350",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "020272",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "001",
        "approval_date": "Dec 29, 1993"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "002",
        "approval_date": "Dec 29, 1993"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "3MG",
        "product_no": "003",
        "approval_date": "Dec 29, 1993"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "4MG",
        "product_no": "004",
        "approval_date": "Dec 29, 1993"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG",
        "product_no": "005",
        "approval_date": "Dec 29, 1993"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "0.5MG",
        "product_no": "007",
        "approval_date": "Jan 27, 1999"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "0.25MG",
        "product_no": "008",
        "approval_date": "May 10, 1999"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "RISPERIDONE",
  "proprietary_name": "RISPERDAL",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA020272",
  "marketing_category": "NDA",
  "nonproprietary_name": "risperidone",
  "start_marketing_date": "19931229",
  "active_numerator_strength": "4"
}

Related drugs

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