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United States · US · US:70518-3721_4f80edc6-df4e-bc19-e063-6294a90ada37
Spironolactone
In shortageOrange BookUNIISPLATC C03DA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerREMEDYREPACK INC.
CountryUS (United States)
ATC codeC03DA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11705183721030 TABLET, COATED in 1 BLISTER PACK (70518-3721-0)
- ndc11705183721230 TABLET, COATED in 1 BOTTLE, PLASTIC (70518-3721-2)
- ndc117051837213100 POUCH in 1 BOX (70518-3721-3) / 1 TABLET, COATED in 1 POUCH (70518-3721-4)
Annotations
UNII (FDA Substance ID)
27O7W4T232
SPIRONOLACTONE
RxCUI 9997
Orange Book
A040750
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": "70518-3721_4f80edc6-df4e-bc19-e063-6294a90ada37",
"productndc": "70518-3721",
"dosage_form": "TABLET, COATED",
"orange_book": {
"appl_no": "040750",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG",
"product_no": "001",
"approval_date": "Aug 29, 2006"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "002",
"approval_date": "Aug 29, 2006"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "003",
"approval_date": "Aug 29, 2006"
}
],
"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": "ANDA040750",
"marketing_category": "ANDA",
"nonproprietary_name": "Spironolactone",
"start_marketing_date": "20230424",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code C03DA01.
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