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United States · US · US:69238-2027_e25b36dd-7948-4481-8994-13658f1f337f
Spironolactone
In shortageOrange BookUNIISPLATC C03DA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals NY LLC
CountryUS (United States)
ATC codeC03DA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc116923820272473 mL in 1 BOTTLE (69238-2027-2)
- ndc116923820278118 mL in 1 BOTTLE (69238-2027-8)
Annotations
UNII (FDA Substance ID)
27O7W4T232
SPIRONOLACTONE
RxCUI 9997
Orange Book
A215572
AB
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": "69238-2027_e25b36dd-7948-4481-8994-13658f1f337f",
"productndc": "69238-2027",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "215572",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG/5ML",
"product_no": "001",
"approval_date": "Sep 5, 2023"
}
],
"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/5mL",
"application_number": "ANDA215572",
"marketing_category": "ANDA",
"nonproprietary_name": "Spironolactone",
"start_marketing_date": "20230908",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code C03DA01.
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