Spironolactone

In shortageOrange BookUNIISPLATC C03DA01

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

Identification

ManufacturerOxford Pharmaceuticals, LLC

CountryUS (United States)

ATC codeC03DA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
6958485309
90 TABLET, COATED in 1 BOTTLE (69584-853-09)
ndc11
6958485310
100 TABLET, COATED in 1 BOTTLE (69584-853-10)
ndc11
6958485350
500 TABLET, COATED in 1 BOTTLE (69584-853-50)
ndc11
6958485390
1000 TABLET, COATED in 1 BOTTLE (69584-853-90)

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": "69584-853_70be7336-8f41-4960-b57d-7830ca020481",
  "productndc": "69584-853",
  "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": "50"
}

Related drugs

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