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United States · US · US:68382-660_79b8df9c-5a73-432e-bd16-bbbecd9e2046
spironolactone
In shortageOrange BookUNIISPLATC C03DA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Pharmaceuticals (USA) Inc.
CountryUS (United States)
ATC codeC03DA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc116838266001100 TABLET, FILM COATED in 1 BOTTLE (68382-660-01)
- ndc116838266005500 TABLET, FILM COATED in 1 BOTTLE (68382-660-05)
- ndc11683826600630 TABLET, FILM COATED in 1 BOTTLE (68382-660-06)
- ndc1168382660101000 TABLET, FILM COATED in 1 BOTTLE (68382-660-10)
- ndc11683826601690 TABLET, FILM COATED in 1 BOTTLE (68382-660-16)
- ndc11683826603010 BLISTER PACK in 1 CARTON (68382-660-30) / 10 TABLET, FILM COATED in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
27O7W4T232
SPIRONOLACTONE
RxCUI 9997
Orange Book
A205936
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": "68382-660_79b8df9c-5a73-432e-bd16-bbbecd9e2046",
"productndc": "68382-660",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "205936",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG",
"product_no": "001",
"approval_date": "Jul 18, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "002",
"approval_date": "Jul 18, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "003",
"approval_date": "Jul 18, 2018"
}
],
"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": "ANDA205936",
"marketing_category": "ANDA",
"nonproprietary_name": "spironolactone",
"start_marketing_date": "20180815",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code C03DA01.
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