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United States · US · US:42291-942_3e89b142-2fd6-d340-e063-6294a90a5208
IRBESARTAN
Orange BookUNIISPLATC C09CA04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAvKARE
CountryUS (United States)
ATC codeC09CA04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11422919429090 TABLET in 1 BOTTLE (42291-942-90)
Annotations
UNII (FDA Substance ID)
J0E2756Z7N
IRBESARTAN
RxCUI 83818
Orange Book
A203534
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": "42291-942_3e89b142-2fd6-d340-e063-6294a90a5208",
"productndc": "42291-942",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "203534",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "75MG",
"product_no": "001",
"approval_date": "Feb 23, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "150MG",
"product_no": "002",
"approval_date": "Feb 23, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "300MG",
"product_no": "003",
"approval_date": "Feb 23, 2015"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "IRBESARTAN",
"proprietary_name": "IRBESARTAN",
"active_ingred_unit": "mg/1",
"application_number": "ANDA203534",
"marketing_category": "ANDA",
"nonproprietary_name": "IRBESARTAN",
"start_marketing_date": "20250206",
"active_numerator_strength": "300"
}Related drugs
Other records sharing ATC code C09CA04.
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