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United States · US · US:0024-5852_b36c9035-33ad-4c8f-b47f-030436e0ef4d
Avapro
Orange BookUNIISPLATC C09CA04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSanofi-Aventis U.S. LLC
CountryUS (United States)
ATC codeC09CA04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 0
No packs registered.
Annotations
UNII (FDA Substance ID)
J0E2756Z7N
IRBESARTAN
RxCUI 83818
Orange Book
N020757
ABAB
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": {
"7885b2a8-be4e-48ab-8113-4e6ab791eb98": {
"match": "brand_token",
"title": "AVAPRO (IRBESARTAN) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]",
"spl_version": "21",
"published_date": "2026-03-03"
}
},
"productid": "0024-5852_b36c9035-33ad-4c8f-b47f-030436e0ef4d",
"productndc": "0024-5852",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "020757",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "75MG",
"product_no": "001",
"approval_date": "Sep 30, 1997"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "150MG",
"product_no": "002",
"approval_date": "Sep 30, 1997"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "300MG",
"product_no": "003",
"approval_date": "Sep 30, 1997"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "IRBESARTAN",
"proprietary_name": "Avapro",
"active_ingred_unit": "mg/1",
"application_number": "NDA020757",
"marketing_category": "NDA",
"nonproprietary_name": "irbesartan",
"start_marketing_date": "20130101",
"active_numerator_strength": "300"
}Related drugs
Other records sharing ATC code C09CA04.
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