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United States · US · US:42658-121_422e87bf-8271-64d5-e063-6294a90a63ce
IRBESARTAN
Orange BookUNIISPLATC C09CA04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHisun Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeC09CA04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11426581210130 TABLET, FILM COATED in 1 BOTTLE (42658-121-01)
- ndc11426581210490 TABLET, FILM COATED in 1 BOTTLE (42658-121-04)
Annotations
UNII (FDA Substance ID)
J0E2756Z7N
IRBESARTAN
RxCUI 83818
Orange Book
A206194
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "J0E2756Z7N",
"rxcui": "83818",
"inchikey": "YOSHYTLCDANDAN-UHFFFAOYSA-N",
"display_name": "IRBESARTAN",
"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": "42658-121_422e87bf-8271-64d5-e063-6294a90a63ce",
"productndc": "42658-121",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "206194",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "75MG",
"product_no": "001",
"approval_date": "Jun 14, 2016"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "150MG",
"product_no": "002",
"approval_date": "Jun 14, 2016"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "300MG",
"product_no": "003",
"approval_date": "Jun 14, 2016"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "IRBESARTAN",
"proprietary_name": "IRBESARTAN",
"active_ingred_unit": "mg/1",
"application_number": "ANDA206194",
"marketing_category": "ANDA",
"nonproprietary_name": "IRBESARTAN",
"start_marketing_date": "20170415",
"active_numerator_strength": "75"
}Related drugs
Other records sharing ATC code C09CA04.
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