Thiothixene

Orange BookUNIISPLATC N05AF04

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

Identification

ManufacturerANI Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeN05AF04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
7095401710
100 CAPSULE in 1 BOTTLE (70954-017-10)
ndc11
7095401720
1000 CAPSULE in 1 BOTTLE (70954-017-20)
ndc11
7095401740
100 BLISTER PACK in 1 CARTON (70954-017-40) / 1 CAPSULE in 1 BLISTER PACK (70954-017-30)

Annotations

UNII (FDA Substance ID)

7318FJ13YJ

THIOTHIXENE

RxCUI 10510

Orange Book

A211642

ABABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "7318FJ13YJ",
    "rxcui": "10510",
    "inchikey": "GFBKORZTTCHDGY-UWVJOHFNSA-N",
    "display_name": "THIOTHIXENE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "81c40311-7dc4-4332-8920-a39a8466aea6": {
      "match": "brand_token",
      "title": "THIOTHIXENE CAPSULE [AMNEAL PHARMACEUTICALS NY LLC]",
      "spl_version": "10",
      "published_date": "2026-03-24"
    }
  },
  "productid": "70954-017_92792cc3-5d0e-4105-bf5a-03f2e479b8d7",
  "productndc": "70954-017",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "211642",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "001",
        "approval_date": "Apr 5, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "002",
        "approval_date": "Apr 5, 2019"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "003",
        "approval_date": "Apr 5, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "004",
        "approval_date": "Apr 5, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "THIOTHIXENE",
  "proprietary_name": "Thiothixene",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA211642",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Thiothixene",
  "start_marketing_date": "20190405",
  "active_numerator_strength": "10"
}

Related drugs

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