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 · 7

ndc11
5348950001
100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-500-01)
ndc11
5348950002
50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-500-02)
ndc11
5348950003
250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-500-03)
ndc11
5348950005
500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-500-05)
ndc11
5348950006
60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-500-06)
ndc11
5348950010
1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-500-10)
ndc11
5348950060
20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-500-60)

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": "53489-500_2c96c6f9-3008-48ba-86ea-e9b83502da67",
  "productndc": "53489-500",
  "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": "100"
}

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