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United States · US · US:67544-310_3c92f359-98a1-43c4-b639-58ab3a388ab3
Spironolactone
In shortageOrange BookUNIISPLATC C03DA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAphena Pharma Solutions - Tennessee, LLC
CountryUS (United States)
ATC codeC03DA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11675443103030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67544-310-30)
- ndc11675443104545 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67544-310-45)
- ndc11675443106090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67544-310-60)
Annotations
UNII (FDA Substance ID)
27O7W4T232
SPIRONOLACTONE
RxCUI 9997
Orange Book
A040424
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": "67544-310_3c92f359-98a1-43c4-b639-58ab3a388ab3",
"productndc": "67544-310",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "040424",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG",
"product_no": "001",
"approval_date": "Aug 20, 2001"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "002",
"approval_date": "Aug 20, 2001"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "003",
"approval_date": "Aug 20, 2001"
}
],
"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": "ANDA040424",
"marketing_category": "ANDA",
"nonproprietary_name": "spironolactone",
"start_marketing_date": "19810203",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code C03DA01.
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