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United States · US · US:72789-290_525a6d19-36b9-ca74-e063-6294a90a03cb

Spironolactone

In shortageOrange BookUNIISPLATC C03DA01

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

Identification

ManufacturerPD-Rx Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeC03DA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    7278929030
    30 TABLET, COATED in 1 BOTTLE, PLASTIC (72789-290-30)
  • ndc11
    7278929060
    60 TABLET, COATED in 1 BOTTLE, PLASTIC (72789-290-60)
  • ndc11
    7278929090
    90 TABLET, COATED in 1 BOTTLE, PLASTIC (72789-290-90)
  • ndc11
    7278929095
    1000 TABLET, COATED in 1 BOTTLE, PLASTIC (72789-290-95)

Annotations

UNII (FDA Substance ID)
27O7W4T232
SPIRONOLACTONE
RxCUI 9997
Orange Book
A040750
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": "72789-290_525a6d19-36b9-ca74-e063-6294a90a03cb",
  "productndc": "72789-290",
  "dosage_form": "TABLET, COATED",
  "orange_book": {
    "appl_no": "040750",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Aug 29, 2006"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "Aug 29, 2006"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "003",
        "approval_date": "Aug 29, 2006"
      }
    ],
    "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": "ANDA040750",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Spironolactone",
  "start_marketing_date": "20210104",
  "active_numerator_strength": "25"
}

Related drugs

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