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United States · US · US:65162-292_1a0e1325-40d8-4dde-8655-54f6bd962a4f
Telmisartan
Orange BookUNIISPLATC C09CA07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals LLC
CountryUS (United States)
ATC codeC09CA07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc11651622920330 TABLET in 1 BOTTLE (65162-292-03)
- ndc11651622920990 TABLET in 1 BOTTLE (65162-292-09)
- ndc1165162292111000 TABLET in 1 BOTTLE (65162-292-11)
- ndc116516229250500 TABLET in 1 BOTTLE (65162-292-50)
- ndc1165162292633 BLISTER PACK in 1 CARTON (65162-292-63) / 10 TABLET in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
U5SYW473RQ
TELMISARTAN
RxCUI 73494
Orange Book
A204415
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "U5SYW473RQ",
"rxcui": "73494",
"inchikey": "RMMXLENWKUUMAY-UHFFFAOYSA-N",
"display_name": "TELMISARTAN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"a5ded796-3555-4476-8b37-0cdc88d7594a": {
"match": "brand_token",
"title": "TELMISARTAN TABLET [BRYANT RANCH PREPACK]",
"spl_version": "102",
"published_date": "2026-05-25"
}
},
"productid": "65162-292_1a0e1325-40d8-4dde-8655-54f6bd962a4f",
"productndc": "65162-292",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "204415",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG",
"product_no": "001",
"approval_date": "Sep 8, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "40MG",
"product_no": "002",
"approval_date": "Sep 8, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "80MG",
"product_no": "003",
"approval_date": "Sep 8, 2015"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TELMISARTAN",
"proprietary_name": "Telmisartan",
"active_ingred_unit": "mg/1",
"application_number": "ANDA204415",
"marketing_category": "ANDA",
"nonproprietary_name": "Telmisartan",
"start_marketing_date": "20130531",
"active_numerator_strength": "40"
}Related drugs
Other records sharing ATC code C09CA07.
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