🇺🇸
United States · US · US:71335-2202_427160ef-378f-4945-a022-cbf66cb112cc
Spironolactone and Hydrochlorothiazide
In shortageOrange BookUNIISPLATC C03AA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeC03AA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc117133522021100 TABLET in 1 BOTTLE, PLASTIC (71335-2202-1)
Annotations
UNII (FDA Substance ID)
0J48LPH2TH
HYDROCHLOROTHIAZIDE
RxCUI 5487
Orange Book
A089534
AB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Hydrochlorothiazide; Quinapril Hydrochloride Tablet
Raw payload (JSON)
{
"unii": {
"unii": "0J48LPH2TH",
"rxcui": "5487",
"inchikey": "JZUFKLXOESDKRF-UHFFFAOYSA-N",
"display_name": "HYDROCHLOROTHIAZIDE",
"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": "71335-2202_427160ef-378f-4945-a022-cbf66cb112cc",
"productndc": "71335-2202",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "089534",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG;25MG",
"product_no": "001",
"approval_date": "Jul 2, 1987"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "HYDROCHLOROTHIAZIDE; SPIRONOLACTONE",
"shortage_reason": "Hydrochlorothiazide; Quinapril Hydrochloride Tablet",
"shortage_status": "current",
"proprietary_name": "Spironolactone and Hydrochlorothiazide",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA089534",
"marketing_category": "ANDA",
"nonproprietary_name": "Spironolactone and Hydrochlorothiazide",
"start_marketing_date": "19870702",
"active_numerator_strength": "25; 25"
}Related drugs
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