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United States · US · US:62332-043_e21c14f4-6c8c-4676-b479-dff181ec3fa1
IRBESARTAN
Orange BookUNIISPLATC C09CA04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAlembic Pharmaceuticals Inc.
CountryUS (United States)
ATC codeC09CA04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc11623320433030 TABLET in 1 BOTTLE (62332-043-30)
- ndc116233204331100 TABLET in 1 BOTTLE (62332-043-31)
- ndc116233204371500 TABLET in 1 BOTTLE (62332-043-71)
- ndc11623320439090 TABLET in 1 BOTTLE (62332-043-90)
- ndc1162332043911000 TABLET in 1 BOTTLE (62332-043-91)
Annotations
UNII (FDA Substance ID)
J0E2756Z7N
IRBESARTAN
RxCUI 83818
Orange Book
A091236
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": "62332-043_e21c14f4-6c8c-4676-b479-dff181ec3fa1",
"productndc": "62332-043",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "091236",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "75MG",
"product_no": "001",
"approval_date": "Oct 15, 2012"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "150MG",
"product_no": "002",
"approval_date": "Oct 15, 2012"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "300MG",
"product_no": "003",
"approval_date": "Oct 15, 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": "ANDA091236",
"marketing_category": "ANDA",
"nonproprietary_name": "IRBESARTAN",
"start_marketing_date": "20160701",
"active_numerator_strength": "300"
}Related drugs
Other records sharing ATC code C09CA04.
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