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United States · US · US:42571-228_f2aa8284-f86c-3425-e053-2995a90a6dc6
TELMISARTAN
Orange BookUNIISPLATC C09CA07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMicro Labs Limited
CountryUS (United States)
ATC codeC09CA07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc114257122805500 TABLET in 1 BOTTLE (42571-228-05)
- ndc1142571228101000 TABLET in 1 BOTTLE (42571-228-10)
- ndc11425712281110 BLISTER PACK in 1 CARTON (42571-228-11) / 10 TABLET in 1 BLISTER PACK (42571-228-32)
- ndc11425712283030 TABLET in 1 BOTTLE (42571-228-30)
- ndc1142571228413 TABLET in 1 CARTON (42571-228-41)
- ndc11425712289090 TABLET in 1 BOTTLE (42571-228-90)
Annotations
UNII (FDA Substance ID)
U5SYW473RQ
TELMISARTAN
RxCUI 73494
Orange Book
A207016
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": "42571-228_f2aa8284-f86c-3425-e053-2995a90a6dc6",
"productndc": "42571-228",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "207016",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG",
"product_no": "001",
"approval_date": "Oct 3, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "40MG",
"product_no": "002",
"approval_date": "Oct 3, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "80MG",
"product_no": "003",
"approval_date": "Oct 3, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TELMISARTAN",
"proprietary_name": "TELMISARTAN",
"active_ingred_unit": "mg/1",
"application_number": "ANDA207016",
"marketing_category": "ANDA",
"nonproprietary_name": "Telmisartan",
"start_marketing_date": "20180101",
"active_numerator_strength": "80"
}Related drugs
Other records sharing ATC code C09CA07.
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