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United States · US · US:71335-0401_0e49f997-9d03-427b-9331-df38a267fd43
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
- ndc11713350401130 TABLET, FILM COATED in 1 BOTTLE (71335-0401-1)
- ndc11713350401260 TABLET, FILM COATED in 1 BOTTLE (71335-0401-2)
- ndc11713350401390 TABLET, FILM COATED in 1 BOTTLE (71335-0401-3)
- ndc117133504014100 TABLET, FILM COATED in 1 BOTTLE (71335-0401-4)
- ndc11713350401514 TABLET, FILM COATED in 1 BOTTLE (71335-0401-5)
- ndc11713350401610 TABLET, FILM COATED in 1 BOTTLE (71335-0401-6)
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": "71335-0401_0e49f997-9d03-427b-9331-df38a267fd43",
"productndc": "71335-0401",
"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": "50"
}Related drugs
Other records sharing ATC code C03DA01.
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