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United States · US · US:65841-804_9e0aa50a-1fac-4086-b7b6-811cec3f524b
telmisartan
Orange BookUNIISPLATC C09CA07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Lifesciences Limited
CountryUS (United States)
ATC codeC09CA07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc116584180401100 TABLET in 1 BOTTLE (65841-804-01)
- ndc116584180405500 TABLET in 1 BOTTLE (65841-804-05)
- ndc11658418040630 TABLET in 1 BOTTLE (65841-804-06)
- ndc1165841804101000 TABLET in 1 BOTTLE (65841-804-10)
- ndc11658418041690 TABLET in 1 BOTTLE (65841-804-16)
- ndc11658418047830 BLISTER PACK in 1 CARTON (65841-804-78) / 1 TABLET in 1 BLISTER PACK (65841-804-30)
Annotations
UNII (FDA Substance ID)
U5SYW473RQ
TELMISARTAN
RxCUI 73494
Orange Book
A203325
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": "65841-804_9e0aa50a-1fac-4086-b7b6-811cec3f524b",
"productndc": "65841-804",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "203325",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG",
"product_no": "001",
"approval_date": "Aug 26, 2014"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "40MG",
"product_no": "002",
"approval_date": "Aug 26, 2014"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "80MG",
"product_no": "003",
"approval_date": "Aug 26, 2014"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TELMISARTAN",
"proprietary_name": "telmisartan",
"active_ingred_unit": "mg/1",
"application_number": "ANDA203325",
"marketing_category": "ANDA",
"nonproprietary_name": "telmisartan",
"start_marketing_date": "20140827",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code C09CA07.
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