Risperidone

Orange BookUNIISPLATC N05AX08

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

Identification

ManufacturerAmici Pharma, Inc.

CountryUS (United States)

ATC codeN05AX08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6929257528
7 BLISTER PACK in 1 CARTON (69292-575-28) / 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

L6UH7ZF8HC

RISPERIDONE

RxCUI 35636

Orange Book

A077328

ABABABABAB

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": "69292-575_616a890a-5d6d-448b-a6d0-24759f601731",
  "productndc": "69292-575",
  "dosage_form": "TABLET, ORALLY DISINTEGRATING",
  "orange_book": {
    "appl_no": "077328",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.5MG",
        "product_no": "001",
        "approval_date": "Feb 24, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "002",
        "approval_date": "Oct 5, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "003",
        "approval_date": "Feb 24, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "3MG",
        "product_no": "004",
        "approval_date": "Nov 30, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "4MG",
        "product_no": "005",
        "approval_date": "Nov 30, 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": "ANDA077328",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Risperidone",
  "start_marketing_date": "20260401",
  "active_numerator_strength": "4"
}

Related drugs

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