Spironolactone

In shortageOrange BookUNIISPLATC C03DA01

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

Identification

ManufacturerAmneal Pharmaceuticals LLC

CountryUS (United States)

ATC codeC03DA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 7

ndc11
6516251103
30 TABLET in 1 BOTTLE (65162-511-03)
ndc11
6516251106
60 TABLET in 1 BOTTLE (65162-511-06)
ndc11
6516251109
90 TABLET in 1 BOTTLE (65162-511-09)
ndc11
6516251110
100 TABLET in 1 BOTTLE (65162-511-10)
ndc11
6516251111
1000 TABLET in 1 BOTTLE (65162-511-11)
ndc11
6516251150
500 TABLET in 1 BOTTLE (65162-511-50)
ndc11
6516251160
100 TABLET in 1 BLISTER PACK (65162-511-60)

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": "65162-511_8cdb3181-3666-48aa-a197-fb3a1e082e74",
  "productndc": "65162-511",
  "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

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