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United States · US · US:31722-730_4cd3482f-1ad1-1839-e063-6394a90a44d3
Irbesartan
Orange BookUNIISPLATC C09CA04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCamber Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeC09CA04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc113172273005500 TABLET in 1 BOTTLE (31722-730-05)
- ndc1131722730101000 TABLET in 1 BOTTLE (31722-730-10)
- ndc11317227303030 TABLET in 1 BOTTLE (31722-730-30)
- ndc113172273031120 BLISTER PACK in 1 CARTON (31722-730-31) / 10 TABLET in 1 BLISTER PACK
- ndc11317227309090 TABLET in 1 BOTTLE (31722-730-90)
Annotations
UNII (FDA Substance ID)
J0E2756Z7N
IRBESARTAN
RxCUI 83818
Orange Book
A202910
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": "31722-730_4cd3482f-1ad1-1839-e063-6394a90a44d3",
"productndc": "31722-730",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "202910",
"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": "ANDA202910",
"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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