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United States · US · US:70518-1543_494be1b4-f986-f70d-e063-6294a90a1704
Irbesartan
Orange BookUNIISPLATC C09CA04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerREMEDYREPACK INC.
CountryUS (United States)
ATC codeC09CA04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11705181543190 TABLET in 1 BOTTLE, PLASTIC (70518-1543-1)
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": "70518-1543_494be1b4-f986-f70d-e063-6294a90a1704",
"productndc": "70518-1543",
"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": "20181017",
"active_numerator_strength": "300"
}Related drugs
Other records sharing ATC code C09CA04.
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