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United States · US · US:71205-146_5857334b-cd0a-47c8-ba29-b8ba367162fa
Spironolactone
In shortageOrange BookUNIISPLATC C03DA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeC03DA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11712051463030 TABLET, FILM COATED in 1 BOTTLE (71205-146-30)
- ndc11712051466060 TABLET, FILM COATED in 1 BOTTLE (71205-146-60)
- ndc11712051469090 TABLET, FILM COATED in 1 BOTTLE (71205-146-90)
Annotations
UNII (FDA Substance ID)
27O7W4T232
SPIRONOLACTONE
RxCUI 9997
Orange Book
A203512
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": "71205-146_5857334b-cd0a-47c8-ba29-b8ba367162fa",
"productndc": "71205-146",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "203512",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG",
"product_no": "001",
"approval_date": "Sep 19, 2016"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "002",
"approval_date": "Sep 19, 2016"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "003",
"approval_date": "Sep 19, 2016"
}
],
"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": "ANDA203512",
"marketing_category": "ANDA",
"nonproprietary_name": "spironolactone",
"start_marketing_date": "20170602",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code C03DA01.
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