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United States · US · US:63187-737_0adbcb7c-cbd5-49b6-99a4-cdd876ac278a
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 · 4
- ndc11631877371010 BLISTER PACK in 1 CARTON (63187-737-10) / 10 TABLET in 1 BLISTER PACK
- ndc11631877373030 TABLET in 1 BOTTLE (63187-737-30)
- ndc11631877376060 TABLET in 1 BOTTLE (63187-737-60)
- ndc11631877379090 TABLET in 1 BOTTLE (63187-737-90)
Annotations
UNII (FDA Substance ID)
J0E2756Z7N
IRBESARTAN
RxCUI 83818
Orange Book
A202254
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": "63187-737_0adbcb7c-cbd5-49b6-99a4-cdd876ac278a",
"productndc": "63187-737",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "202254",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "75MG",
"product_no": "001",
"approval_date": "Oct 3, 2012"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "150MG",
"product_no": "002",
"approval_date": "Oct 3, 2012"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "300MG",
"product_no": "003",
"approval_date": "Oct 3, 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": "ANDA202254",
"marketing_category": "ANDA",
"nonproprietary_name": "Irbesartan",
"start_marketing_date": "20120927",
"active_numerator_strength": "150"
}Related drugs
Other records sharing ATC code C09CA04.
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