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United States · US · US:50111-916_4ff14943-97b8-4b1c-8600-95c1e3540008

Torsemide

Orange BookUNIISPLATC C03CA04

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerTeva Pharmaceuticals USA, Inc.
CountryUS (United States)
ATC codeC03CA04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5011191601
    100 TABLET in 1 BOTTLE (50111-916-01)

Annotations

UNII (FDA Substance ID)
W31X2H97FB
TORSEMIDE
RxCUI 38413
Orange Book
A076346
ABABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "W31X2H97FB",
    "rxcui": "38413",
    "inchikey": "NGBFQHCMQULJNZ-UHFFFAOYSA-N",
    "display_name": "TORSEMIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "09305350-e317-419c-96f5-aa8fbeb4044d": {
      "match": "brand_token",
      "title": "TORSEMIDE TABLET [MAJOR PHARMACEUTICALS]",
      "spl_version": "4",
      "published_date": "2026-04-02"
    }
  },
  "productid": "50111-916_4ff14943-97b8-4b1c-8600-95c1e3540008",
  "productndc": "50111-916",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "076346",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "May 30, 2003"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "May 30, 2003"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "003",
        "approval_date": "May 30, 2003"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "004",
        "approval_date": "Oct 19, 2004"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TORSEMIDE",
  "proprietary_name": "Torsemide",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA076346",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Torsemide",
  "start_marketing_date": "20040601",
  "active_numerator_strength": "10"
}

Related drugs

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