Spironolactone

In shortageOrange BookUNIISPLATC C03DA01

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

Identification

ManufacturerAphena Pharma Solutions - Tennessee, LLC

CountryUS (United States)

ATC codeC03DA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7161010260
90 TABLET in 1 BOTTLE (71610-102-60)

Annotations

UNII (FDA Substance ID)

27O7W4T232

SPIRONOLACTONE

RxCUI 9997

Orange Book

A091426

ABABAB

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Spironolactone Tablet

Raw payload (JSON)

{
  "unii": {
    "unii": "27O7W4T232",
    "rxcui": "9997",
    "inchikey": "LXMSZDCAJNLERA-ZHYRCANASA-N",
    "display_name": "SPIRONOLACTONE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "3487305c-25a6-4e82-923c-3e4dd638c988": {
      "match": "brand_token",
      "title": "SPIRONOLACTONE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]",
      "spl_version": "16",
      "published_date": "2026-06-01"
    }
  },
  "productid": "71610-102_c9e366cc-e9b4-4e14-8c40-8daf2fe265ad",
  "productndc": "71610-102",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "091426",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Jul 2, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "Jul 2, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "003",
        "approval_date": "Jul 2, 2010"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SPIRONOLACTONE",
  "shortage_reason": "Spironolactone Tablet",
  "shortage_status": "current",
  "proprietary_name": "Spironolactone",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA091426",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Spironolactone",
  "start_marketing_date": "20100802",
  "active_numerator_strength": "25"
}

Related drugs

Other records sharing ATC code C03DA01.

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