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United States · US · US:72162-1627_a6caa2b8-b27e-47eb-9db8-ccfa8e8b6a8b
SPIRONOLACTONE
In shortageOrange BookUNIISPLATC C03DA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeC03DA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc117216216271100 TABLET, FILM COATED in 1 BOTTLE (72162-1627-1)
- ndc117216216272100 TABLET, FILM COATED in 1 BOTTLE (72162-1627-2)
- ndc11721621627330 TABLET, FILM COATED in 1 BOTTLE (72162-1627-3)
- ndc11721621627460 TABLET, FILM COATED in 1 BOTTLE (72162-1627-4)
- ndc117216216275500 TABLET, FILM COATED in 1 BOTTLE (72162-1627-5)
- ndc11721621627730 TABLET, FILM COATED in 1 BOTTLE (72162-1627-7)
Annotations
UNII (FDA Substance ID)
27O7W4T232
SPIRONOLACTONE
RxCUI 9997
Orange Book
A089424
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": "72162-1627_a6caa2b8-b27e-47eb-9db8-ccfa8e8b6a8b",
"productndc": "72162-1627",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "089424",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG",
"product_no": "001",
"approval_date": "Jul 23, 1986"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "002",
"approval_date": "Aug 11, 1999"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "003",
"approval_date": "Aug 11, 1999"
}
],
"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": "ANDA089424",
"marketing_category": "ANDA",
"nonproprietary_name": "SPIRONOLACTONE",
"start_marketing_date": "19860723",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code C03DA01.
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