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United States · US · US:71205-082_b40bb16b-4019-4002-8d5e-64c5f887f10b
Irbesartan
Orange BookUNIISPLATC C09CA04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeC09CA04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11712050823030 TABLET in 1 BOTTLE (71205-082-30)
- ndc11712050826060 TABLET in 1 BOTTLE (71205-082-60)
- ndc11712050829090 TABLET in 1 BOTTLE (71205-082-90)
Annotations
UNII (FDA Substance ID)
J0E2756Z7N
IRBESARTAN
RxCUI 83818
Orange Book
A203071
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": "71205-082_b40bb16b-4019-4002-8d5e-64c5f887f10b",
"productndc": "71205-082",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "203071",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "75MG",
"product_no": "001",
"approval_date": "Sep 27, 2012"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "150MG",
"product_no": "002",
"approval_date": "Sep 27, 2012"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "300MG",
"product_no": "003",
"approval_date": "Sep 27, 2012"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "IRBESARTAN",
"proprietary_name": "Irbesartan",
"active_ingred_unit": "mg/1",
"application_number": "ANDA203071",
"marketing_category": "ANDA",
"nonproprietary_name": "Irbesartan",
"start_marketing_date": "20160613",
"active_numerator_strength": "150"
}Related drugs
Other records sharing ATC code C09CA04.
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