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United States · US · US:68462-201_7e08eda5-be87-4e09-ae4e-880a18aa7a0b
Telmisartan
Orange BookUNIISPLATC C09CA07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGlenmark Pharmaceuticals Inc., USA
CountryUS (United States)
ATC codeC09CA07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc116846220101100 TABLET in 1 BOTTLE (68462-201-01)
- ndc1168462201133 BLISTER PACK in 1 CARTON (68462-201-13) / 10 TABLET in 1 BLISTER PACK
- ndc11684622013030 TABLET in 1 BOTTLE (68462-201-30)
- ndc1168462201784 BLISTER PACK in 1 CARTON (68462-201-78) / 10 TABLET in 1 BLISTER PACK
- ndc11684622019090 TABLET in 1 BOTTLE (68462-201-90)
Annotations
UNII (FDA Substance ID)
U5SYW473RQ
TELMISARTAN
RxCUI 73494
Orange Book
A090032
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": "68462-201_7e08eda5-be87-4e09-ae4e-880a18aa7a0b",
"productndc": "68462-201",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "090032",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG",
"product_no": "001",
"approval_date": "Jul 7, 2014"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "40MG",
"product_no": "002",
"approval_date": "Jul 7, 2014"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "80MG",
"product_no": "003",
"approval_date": "Jul 7, 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": "ANDA090032",
"marketing_category": "ANDA",
"nonproprietary_name": "Telmisartan",
"start_marketing_date": "20140707",
"active_numerator_strength": "80"
}Related drugs
Other records sharing ATC code C09CA07.
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