🇺🇸
United States · US · US:65862-639_9e17df53-3757-4012-a76f-d1aa0053fda0
Irbesartan
Orange BookUNIISPLATC C09CA04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeC09CA04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc116586263905500 TABLET in 1 BOTTLE (65862-639-05)
- ndc11658626393030 TABLET in 1 BOTTLE (65862-639-30)
- ndc11658626397810 BLISTER PACK in 1 CARTON (65862-639-78) / 10 TABLET in 1 BLISTER PACK (65862-639-10)
- ndc11658626399090 TABLET in 1 BOTTLE (65862-639-90)
Annotations
UNII (FDA Substance ID)
J0E2756Z7N
IRBESARTAN
RxCUI 83818
Orange Book
A203081
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": "65862-639_9e17df53-3757-4012-a76f-d1aa0053fda0",
"productndc": "65862-639",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "203081",
"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": "ANDA203081",
"marketing_category": "ANDA",
"nonproprietary_name": "Irbesartan",
"start_marketing_date": "20120927",
"active_numerator_strength": "300"
}Related drugs
Other records sharing ATC code C09CA04.
Access this data programmatically
Query Irbesartan and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.