🇺🇸
United States · US · US:68462-329_770b4914-a475-4841-83f8-79261f115eff
Trandolapril and Verapamil Hydrochloride
Orange BookUNIISPLATC C09AA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGlenmark Pharmaceuticals Inc., USA
CountryUS (United States)
ATC codeC09AA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc116846232901100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-329-01)
- ndc1168462329101000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-329-10)
Annotations
UNII (FDA Substance ID)
1T0N3G9CRC
TRANDOLAPRIL
RxCUI 38454
Orange Book
A079135
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": "68462-329_770b4914-a475-4841-83f8-79261f115eff",
"productndc": "68462-329",
"dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
"orange_book": {
"appl_no": "079135",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "2MG;180MG",
"product_no": "001",
"approval_date": "May 26, 2010"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "2MG;240MG",
"product_no": "002",
"approval_date": "May 26, 2010"
},
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "4MG;240MG",
"product_no": "003",
"approval_date": "May 5, 2010"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "1MG;240MG",
"product_no": "004",
"approval_date": "Aug 30, 2010"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE",
"proprietary_name": "Trandolapril and Verapamil Hydrochloride",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA079135",
"marketing_category": "ANDA",
"nonproprietary_name": "Trandolapril and Verapamil Hydrochloride",
"start_marketing_date": "20150225",
"active_numerator_strength": "4; 240"
}Related drugs
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