🇺🇸
United States · US · US:70771-1028_038310cc-d190-4868-9442-00f7222d0597
spironolactone
In shortageOrange BookUNIISPLATC C03DA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Lifesciences Limited
CountryUS (United States)
ATC codeC03DA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc1170771102801000 TABLET, FILM COATED in 1 BOTTLE (70771-1028-0)
- ndc117077110281100 TABLET, FILM COATED in 1 BOTTLE (70771-1028-1)
- ndc11707711028330 TABLET, FILM COATED in 1 BOTTLE (70771-1028-3)
- ndc11707711028410 BLISTER PACK in 1 CARTON (70771-1028-4) / 10 TABLET, FILM COATED in 1 BLISTER PACK
- ndc117077110285500 TABLET, FILM COATED in 1 BOTTLE (70771-1028-5)
- ndc11707711028990 TABLET, FILM COATED in 1 BOTTLE (70771-1028-9)
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": "70771-1028_038310cc-d190-4868-9442-00f7222d0597",
"productndc": "70771-1028",
"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": "50"
}Related drugs
Other records sharing ATC code C03DA01.
Access this data programmatically
Query spironolactone and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.