Risperidone

Orange BookUNIISPLATC N05AX08

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

Identification

ManufacturerJubilant Cadista Pharmacuticals Inc.

CountryUS (United States)

ATC codeN05AX08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
5974622105
500 TABLET in 1 BOTTLE (59746-221-05)
ndc11
5974622160
60 TABLET in 1 BOTTLE (59746-221-60)

Annotations

UNII (FDA Substance ID)

L6UH7ZF8HC

RISPERIDONE

RxCUI 35636

Orange Book

A078828

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": {
    "43aa2a4f-1123-4f86-800b-9218882f7bcd": {
      "match": "brand_token",
      "title": "RISPERIDONE TABLET [SOLCO HEALTHCARE US, LLC]",
      "spl_version": "14",
      "published_date": "2026-05-26"
    }
  },
  "productid": "59746-221_39d41b28-93eb-446b-9652-7432858ccbab",
  "productndc": "59746-221",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "078828",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.25MG",
        "product_no": "001",
        "approval_date": "Mar 23, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.5MG",
        "product_no": "002",
        "approval_date": "Mar 23, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "003",
        "approval_date": "Mar 23, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "004",
        "approval_date": "Mar 23, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "3MG",
        "product_no": "005",
        "approval_date": "Mar 23, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "4MG",
        "product_no": "006",
        "approval_date": "Mar 23, 2009"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "RISPERIDONE",
  "proprietary_name": "Risperidone",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA078828",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Risperidone",
  "start_marketing_date": "20251015",
  "active_numerator_strength": ".25"
}

Related drugs

Other records sharing ATC code N05AX08.

Access this data programmatically

Query Risperidone and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs