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United States · US · US:71335-0130_f904537e-ac4d-407c-8aec-24610020f5a7

RISPERIDONE

Orange BookUNIISPLATC N05AX08

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeN05AX08
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    7133501301
    60 TABLET in 1 BOTTLE (71335-0130-1)
  • ndc11
    7133501302
    30 TABLET in 1 BOTTLE (71335-0130-2)
  • ndc11
    7133501303
    90 TABLET in 1 BOTTLE (71335-0130-3)
  • ndc11
    7133501304
    120 TABLET in 1 BOTTLE (71335-0130-4)

Annotations

UNII (FDA Substance ID)
L6UH7ZF8HC
RISPERIDONE
RxCUI 35636
Orange Book
A201003
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": "71335-0130_f904537e-ac4d-407c-8aec-24610020f5a7",
  "productndc": "71335-0130",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "201003",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.25MG",
        "product_no": "001",
        "approval_date": "Aug 24, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.5MG",
        "product_no": "002",
        "approval_date": "Aug 24, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "003",
        "approval_date": "Aug 24, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "004",
        "approval_date": "Aug 24, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "3MG",
        "product_no": "005",
        "approval_date": "Aug 24, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "4MG",
        "product_no": "006",
        "approval_date": "Aug 24, 2011"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "RISPERIDONE",
  "proprietary_name": "RISPERIDONE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA201003",
  "marketing_category": "ANDA",
  "nonproprietary_name": "RISPERIDONE",
  "start_marketing_date": "20140328",
  "active_numerator_strength": ".5"
}

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