SPIRONOLACTONE

In shortageOrange BookUNIISPLATC C03DA01

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

Identification

ManufacturerSun Pharmaceutical Industries, Inc.

CountryUS (United States)

ATC codeC03DA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 7

ndc11
5348932901
100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-329-01)
ndc11
5348932902
50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-329-02)
ndc11
5348932903
250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-329-03)
ndc11
5348932905
500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-329-05)
ndc11
5348932906
60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-329-06)
ndc11
5348932907
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-329-07)
ndc11
5348932910
1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-329-10)

Annotations

UNII (FDA Substance ID)

27O7W4T232

SPIRONOLACTONE

RxCUI 9997

Orange Book

A089424

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": "53489-329_d58f76e0-60c3-42ec-8375-128cd42485f1",
  "productndc": "53489-329",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "089424",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Jul 23, 1986"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "Aug 11, 1999"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "003",
        "approval_date": "Aug 11, 1999"
      }
    ],
    "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": "ANDA089424",
  "marketing_category": "ANDA",
  "nonproprietary_name": "SPIRONOLACTONE",
  "start_marketing_date": "19860723",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code C03DA01.

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