risperidone

Orange BookUNIISPLATC N05AX08

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

Identification

ManufacturerZydus Pharmaceuticals USA Inc.

CountryUS (United States)

ATC codeN05AX08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
6838211201
100 TABLET, FILM COATED in 1 BOTTLE (68382-112-01)
ndc11
6838211205
500 TABLET, FILM COATED in 1 BOTTLE (68382-112-05)
ndc11
6838211206
30 TABLET, FILM COATED in 1 BOTTLE (68382-112-06)
ndc11
6838211210
1000 TABLET, FILM COATED in 1 BOTTLE (68382-112-10)
ndc11
6838211214
60 TABLET, FILM COATED in 1 BOTTLE (68382-112-14)
ndc11
6838211216
90 TABLET, FILM COATED in 1 BOTTLE (68382-112-16)

Annotations

UNII (FDA Substance ID)

L6UH7ZF8HC

RISPERIDONE

RxCUI 35636

Orange Book

A078040

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": "68382-112_2af53e64-46a6-4b12-9ac8-8f8031a8bd97",
  "productndc": "68382-112",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "078040",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.25MG",
        "product_no": "001",
        "approval_date": "Oct 16, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.5MG",
        "product_no": "002",
        "approval_date": "Oct 16, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "003",
        "approval_date": "Oct 16, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "004",
        "approval_date": "Oct 16, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "3MG",
        "product_no": "005",
        "approval_date": "Oct 16, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "4MG",
        "product_no": "006",
        "approval_date": "Oct 16, 2008"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "RISPERIDONE",
  "proprietary_name": "risperidone",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA078040",
  "marketing_category": "ANDA",
  "nonproprietary_name": "risperidone",
  "start_marketing_date": "20081113",
  "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