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United States · US · US:65862-166_004262f3-c8d0-43c9-a760-641c22748858
Trandolapril
Orange BookUNIISPLATC C09AA10
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeC09AA10
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc116586216601100 TABLET in 1 BOTTLE (65862-166-01)
- ndc1165862166991000 TABLET in 1 BOTTLE (65862-166-99)
Annotations
UNII (FDA Substance ID)
1T0N3G9CRC
TRANDOLAPRIL
RxCUI 38454
Orange Book
A078438
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "1T0N3G9CRC",
"rxcui": "38454",
"inchikey": "VXFJYXUZANRPDJ-WTNASJBWSA-N",
"display_name": "TRANDOLAPRIL",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"39bad727-af4c-4d20-933b-7f287e88099a": {
"match": "brand_token",
"title": "TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]",
"spl_version": "13",
"published_date": "2026-01-30"
}
},
"productid": "65862-166_004262f3-c8d0-43c9-a760-641c22748858",
"productndc": "65862-166",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "078438",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "1MG",
"product_no": "001",
"approval_date": "Jun 12, 2007"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "2MG",
"product_no": "002",
"approval_date": "Jun 12, 2007"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "4MG",
"product_no": "003",
"approval_date": "Jun 12, 2007"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TRANDOLAPRIL",
"proprietary_name": "Trandolapril",
"active_ingred_unit": "mg/1",
"application_number": "ANDA078438",
"marketing_category": "ANDA",
"nonproprietary_name": "Trandolapril",
"start_marketing_date": "20070612",
"active_numerator_strength": "4"
}Related drugs
Other records sharing ATC code C09AA10.
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