SPIRONOLACTONE

In shortageOrange BookUNIISPLATC C03DA01

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

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeC03DA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 9

ndc11
6362918301
30 TABLET in 1 BOTTLE (63629-1830-1)
ndc11
6362918302
60 TABLET in 1 BOTTLE (63629-1830-2)
ndc11
6362918303
90 TABLET in 1 BOTTLE (63629-1830-3)
ndc11
6362918304
14 TABLET in 1 BOTTLE (63629-1830-4)
ndc11
6362918305
100 TABLET in 1 BOTTLE (63629-1830-5)
ndc11
6362918306
7 TABLET in 1 BOTTLE (63629-1830-6)
ndc11
6362918307
10 TABLET in 1 BOTTLE (63629-1830-7)
ndc11
6362918308
180 TABLET in 1 BOTTLE (63629-1830-8)
ndc11
6362918309
45 TABLET in 1 BOTTLE (63629-1830-9)

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": "63629-1830_520b62af-6437-4600-a765-346cf1586071",
  "productndc": "63629-1830",
  "dosage_form": "TABLET",
  "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": "25"
}

Related drugs

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