Thioridazine Hydrochloride

Orange BookUNIISPLATC N05AC02

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

Identification

ManufacturerSun Pharmaceutical Industries, Inc.

CountryUS (United States)

ATC codeN05AC02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
5348915001
100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-150-01)
ndc11
5348915010
1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-150-10)

Annotations

UNII (FDA Substance ID)

4WCI67NK8M

THIORIDAZINE HYDROCHLORIDE

RxCUI 203165

Orange Book

A089953

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "4WCI67NK8M",
    "rxcui": "203165",
    "inchikey": "NZFNXWQNBYZDAQ-UHFFFAOYSA-N",
    "display_name": "THIORIDAZINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "1fd16a99-e856-4a37-9dae-c443714fac14": {
      "match": "brand_token",
      "title": "THIORIDAZINE HYDROCHLORIDE TABLET, FILM COATED [SAFECOR HEALTH LLC]",
      "spl_version": "2",
      "published_date": "2026-03-04"
    }
  },
  "productid": "53489-150_2c96c6f9-3008-48ba-86ea-e9b83502da67",
  "productndc": "53489-150",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "089953",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Oct 7, 1988"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "Aug 1, 1986"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "25MG",
        "product_no": "003",
        "approval_date": "Aug 1, 1986"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "004",
        "approval_date": "Aug 1, 1986"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "THIORIDAZINE HYDROCHLORIDE",
  "proprietary_name": "Thioridazine Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA089953",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Thioridazine Hydrochloride",
  "start_marketing_date": "19881007",
  "active_numerator_strength": "50"
}

Related drugs

Other records sharing ATC code N05AC02.

Access this data programmatically

Query Thioridazine Hydrochloride 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