Dyrenium

Orange BookUNIISPLATC C03DB02

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

Identification

ManufacturerAdvanz Pharma (US) Corp.

CountryUS (United States)

ATC codeC03DB02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5921200301
100 CAPSULE in 1 BOTTLE (59212-003-01)

Annotations

UNII (FDA Substance ID)

WS821Z52LQ

TRIAMTERENE

RxCUI 10763

Orange Book

N013174

ABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "WS821Z52LQ",
    "rxcui": "10763",
    "inchikey": "FNYLWPVRPXGIIP-UHFFFAOYSA-N",
    "display_name": "TRIAMTERENE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "ebb177c0-d45d-4443-a85a-e76bd9931a42": {
      "match": "brand_token",
      "title": "DYRENIUM (TRIAMTERENE) CAPSULE [ADVANZ PHARMA (US) CORP.]",
      "spl_version": "11",
      "published_date": "2024-12-24"
    }
  },
  "productid": "59212-003_a617b947-1315-4f6e-8fd2-9697906de9ac",
  "productndc": "59212-003",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "013174",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TRIAMTERENE",
  "proprietary_name": "Dyrenium",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA013174",
  "marketing_category": "NDA",
  "nonproprietary_name": "Triamterene",
  "start_marketing_date": "19990101",
  "active_numerator_strength": "100"
}

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