Thioridazine Hydrochloride

Orange BookUNIISPLATC N05AC02

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

Identification

ManufacturerMylan Pharmaceuticals Inc.

CountryUS (United States)

ATC codeN05AC02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0378061601
100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0616-01)

Annotations

UNII (FDA Substance ID)

4WCI67NK8M

THIORIDAZINE HYDROCHLORIDE

RxCUI 203165

Orange Book

A088004

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": "0378-0616_6437f615-1e2b-4d0a-ba83-a0c14391693d",
  "productndc": "0378-0616",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "088004",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Nov 18, 1983"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Mar 15, 1983"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "25MG",
        "product_no": "003",
        "approval_date": "Mar 15, 1983"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "50MG",
        "product_no": "004",
        "approval_date": "Mar 15, 1983"
      }
    ],
    "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": "ANDA088004",
  "marketing_category": "ANDA",
  "nonproprietary_name": "thioridazine hydrochloride",
  "start_marketing_date": "19830315",
  "active_numerator_strength": "50"
}

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