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United States · US · US:0574-1133_902035fb-dba8-4fdf-9d8d-29d736c07d57
SPIRONOLACTONE
In shortageOrange BookUNIISPLATC C03DA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPadagis US LLC
CountryUS (United States)
ATC codeC03DA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc110574113304118 mL in 1 BOTTLE (0574-1133-04)
- ndc11057411331010 CUP, UNIT-DOSE in 1 CARTON (0574-1133-10) / 5 mL in 1 CUP, UNIT-DOSE (0574-1133-05)
- ndc110574113316473 mL in 1 BOTTLE (0574-1133-16)
Annotations
UNII (FDA Substance ID)
27O7W4T232
SPIRONOLACTONE
RxCUI 9997
Orange Book
N209478
AB
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": "0574-1133_902035fb-dba8-4fdf-9d8d-29d736c07d57",
"productndc": "0574-1133",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "209478",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "25MG/5ML",
"product_no": "001",
"approval_date": "Aug 4, 2017"
}
],
"appl_type": "N"
},
"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/5mL",
"application_number": "NDA209478",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "spironolactone",
"start_marketing_date": "20231031",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code C03DA01.
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