Spironolactone

In shortageOrange BookUNIISPLATC C03DA01

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

Identification

ManufacturerAmneal Pharmaceuticals of New York LLC

CountryUS (United States)

ATC codeC03DA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
5374651501
100 TABLET in 1 BOTTLE (53746-515-01)
ndc11
5374651505
500 TABLET in 1 BOTTLE (53746-515-05)
ndc11
5374651510
1000 TABLET in 1 BOTTLE (53746-515-10)
ndc11
5374651530
30 TABLET in 1 BOTTLE (53746-515-30)
ndc11
5374651560
60 TABLET in 1 BOTTLE (53746-515-60)
ndc11
5374651590
90 TABLET in 1 BOTTLE (53746-515-90)

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": "53746-515_0b757d66-e1f0-4d56-bbe0-2f0941f0a35e",
  "productndc": "53746-515",
  "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": "100"
}

Related drugs

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