🇺🇸
United States · US · US:71335-1787_1c842673-6489-419f-a5f3-7a3454a43efb
Irbesartan 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 · 3
- ndc11713351787130 TABLET in 1 BOTTLE (71335-1787-1)
- ndc11713351787290 TABLET in 1 BOTTLE (71335-1787-2)
- ndc11713351787328 TABLET in 1 BOTTLE (71335-1787-3)
Annotations
UNII (FDA Substance ID)
0J48LPH2TH
HYDROCHLOROTHIAZIDE
RxCUI 5487
Orange Book
A090351
ABABAB
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": {
"85494404-484c-45a1-8487-f9eb2a76490d": {
"match": "brand_token",
"title": "IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [BRYANT RANCH PREPACK]",
"spl_version": "103",
"published_date": "2026-06-01"
}
},
"productid": "71335-1787_1c842673-6489-419f-a5f3-7a3454a43efb",
"productndc": "71335-1787",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "090351",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "12.5MG;150MG",
"product_no": "001",
"approval_date": "Oct 15, 2012"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "12.5MG;300MG",
"product_no": "002",
"approval_date": "Oct 15, 2012"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG;300MG",
"product_no": "003",
"approval_date": "Jun 8, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "HYDROCHLOROTHIAZIDE; IRBESARTAN",
"shortage_reason": "Hydrochlorothiazide; Quinapril Hydrochloride Tablet",
"shortage_status": "current",
"proprietary_name": "Irbesartan and Hydrochlorothiazide",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA090351",
"marketing_category": "ANDA",
"nonproprietary_name": "Irbesartan and Hydrochlorothiazide",
"start_marketing_date": "20121015",
"active_numerator_strength": "12.5; 150"
}Related drugs
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