🇺🇸
United States · US · US:68382-471_99f660d2-4407-490e-a79f-6523bece714d
telmisartan
Orange BookUNIISPLATC C09CA07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeC09CA07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc116838247101100 TABLET in 1 BOTTLE (68382-471-01)
- ndc116838247105500 TABLET in 1 BOTTLE (68382-471-05)
- ndc11683824710630 TABLET in 1 BOTTLE (68382-471-06)
- ndc1168382471101000 TABLET in 1 BOTTLE (68382-471-10)
- ndc11683824711690 TABLET in 1 BOTTLE (68382-471-16)
- ndc11683824717830 BLISTER PACK in 1 CARTON (68382-471-78) / 1 TABLET in 1 BLISTER PACK (68382-471-30)
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": "68382-471_99f660d2-4407-490e-a79f-6523bece714d",
"productndc": "68382-471",
"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.
Access this data programmatically
Query telmisartan and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.