🇺🇸
United States · US · US:48433-090_51280203-1fde-d085-e063-6394a90a1a04
Spironolactone and Hydrochlorothiazide
In shortageOrange BookUNIISPLATC C03AA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSafecor Health LLC
CountryUS (United States)
ATC codeC03AA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc114843309020100 BLISTER PACK in 1 CARTON (48433-090-20) / 1 TABLET in 1 BLISTER PACK (48433-090-01)
Annotations
UNII (FDA Substance ID)
0J48LPH2TH
HYDROCHLOROTHIAZIDE
RxCUI 5487
Orange Book
A086513
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": "48433-090_51280203-1fde-d085-e063-6394a90a1a04",
"productndc": "48433-090",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "086513",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG;25MG",
"product_no": "001",
"approval_date": "Approved Prior to Jan 1, 1982"
}
],
"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": "ANDA086513",
"marketing_category": "ANDA",
"nonproprietary_name": "spironolactone and hydrochlorothiazide",
"start_marketing_date": "20260505",
"active_numerator_strength": "25; 25"
}Related drugs
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