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United States · US · US:0025-1041_22946678-dcad-4518-9bc6-cbdf51a38c16
Aldactone
In shortageOrange BookUNIISPLATC C03DA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPfizer Laboratories Div Pfizer Inc
CountryUS (United States)
ATC codeC03DA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 0
No packs registered.
Annotations
UNII (FDA Substance ID)
27O7W4T232
SPIRONOLACTONE
RxCUI 9997
Orange Book
N012151
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": {
"0fed2822-3a03-4b64-9857-c682fcd462bc": {
"match": "brand_token",
"title": "ALDACTONE (SPIRONOLACTONE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]",
"spl_version": "25",
"published_date": "2025-12-01"
}
},
"productid": "0025-1041_22946678-dcad-4518-9bc6-cbdf51a38c16",
"productndc": "0025-1041",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "012151",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "50MG",
"product_no": "008",
"approval_date": "Dec 30, 1982"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "25MG",
"product_no": "009",
"approval_date": "Dec 30, 1983"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "100MG",
"product_no": "010",
"approval_date": "Dec 30, 1983"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SPIRONOLACTONE",
"shortage_reason": "Spironolactone Tablet",
"shortage_status": "current",
"proprietary_name": "Aldactone",
"active_ingred_unit": "mg/1",
"application_number": "NDA012151",
"marketing_category": "NDA",
"nonproprietary_name": "spironolactone",
"start_marketing_date": "19600121",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code C03DA01.
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