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
6838211701
100 TABLET, FILM COATED in 1 BOTTLE (68382-117-01)
ndc11
6838211705
500 TABLET, FILM COATED in 1 BOTTLE (68382-117-05)
ndc11
6838211706
30 TABLET, FILM COATED in 1 BOTTLE (68382-117-06)
ndc11
6838211710
1000 TABLET, FILM COATED in 1 BOTTLE (68382-117-10)
ndc11
6838211714
60 TABLET, FILM COATED in 1 BOTTLE (68382-117-14)
ndc11
6838211716
90 TABLET, FILM COATED in 1 BOTTLE (68382-117-16)

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": "68382-117_2af53e64-46a6-4b12-9ac8-8f8031a8bd97",
  "productndc": "68382-117",
  "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": "4"
}

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