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United States · US · US:53746-293_77cf7b02-2f68-41ff-be0d-8ad569613822
Telmisartan
Orange BookUNIISPLATC C09CA07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals of New York LLC
CountryUS (United States)
ATC codeC09CA07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11537462933030 TABLET in 1 BOTTLE (53746-293-30)
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": "53746-293_77cf7b02-2f68-41ff-be0d-8ad569613822",
"productndc": "53746-293",
"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": "20160925",
"active_numerator_strength": "80"
}Related drugs
Other records sharing ATC code C09CA07.
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