🇺🇸
United States · US · US:72205-329_1f98fd95-e564-45b3-947f-45eba77f2af5
Irbesartan
Orange BookUNIISPLATC C09CA04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNovadoz Pharmaceuticals LLC
CountryUS (United States)
ATC codeC09CA04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc117220532905500 TABLET, FILM COATED in 1 BOTTLE (72205-329-05)
- ndc11722053290610 BLISTER PACK in 1 CARTON (72205-329-06) / 10 TABLET, FILM COATED in 1 BLISTER PACK
- ndc11722053293030 TABLET, FILM COATED in 1 BOTTLE (72205-329-30)
- ndc11722053299090 TABLET, FILM COATED in 1 BOTTLE (72205-329-90)
- ndc1172205329991000 TABLET, FILM COATED in 1 BOTTLE (72205-329-99)
Annotations
UNII (FDA Substance ID)
J0E2756Z7N
IRBESARTAN
RxCUI 83818
Orange Book
A219539
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": "72205-329_1f98fd95-e564-45b3-947f-45eba77f2af5",
"productndc": "72205-329",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "219539",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "75MG",
"product_no": "001",
"approval_date": "Nov 4, 2025"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "150MG",
"product_no": "002",
"approval_date": "Nov 4, 2025"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "300MG",
"product_no": "003",
"approval_date": "Nov 4, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "IRBESARTAN",
"proprietary_name": "Irbesartan",
"active_ingred_unit": "mg/1",
"application_number": "ANDA219539",
"marketing_category": "ANDA",
"nonproprietary_name": "Irbesartan",
"start_marketing_date": "20251104",
"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.