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United States · US · US:0713-0878_004953ba-fe11-03eb-e063-6394a90a638c
Tribenzor
In shortageOrange BookUNIIATC C08CA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCosette Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeC08CA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11071308783030 TABLET, FILM COATED in 1 BOTTLE (0713-0878-30)
Annotations
UNII (FDA Substance ID)
864V2Q084H
AMLODIPINE BESYLATE
RxCUI 104416
Orange Book
N200175
ABABABABAB
FDA shortage
Currently in shortage
Amlodipine Besylate; Benazepril Hydrochloride Capsule
Raw payload (JSON)
{
"unii": {
"unii": "864V2Q084H",
"rxcui": "104416",
"inchikey": "ZPBWCRDSRKPIDG-UHFFFAOYSA-N",
"display_name": "AMLODIPINE BESYLATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"productid": "0713-0878_004953ba-fe11-03eb-e063-6394a90a638c",
"productndc": "0713-0878",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "200175",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "EQ 5MG BASE;12.5MG;20MG",
"product_no": "001",
"approval_date": "Jul 23, 2010"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "EQ 5MG BASE;12.5MG;40MG",
"product_no": "002",
"approval_date": "Jul 23, 2010"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "EQ 5MG BASE;25MG;40MG",
"product_no": "003",
"approval_date": "Jul 23, 2010"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "EQ 10MG BASE;12.5MG;40MG",
"product_no": "004",
"approval_date": "Jul 23, 2010"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "EQ 10MG BASE;25MG;40MG",
"product_no": "005",
"approval_date": "Jul 23, 2010"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL",
"shortage_reason": "Amlodipine Besylate; Benazepril Hydrochloride Capsule",
"shortage_status": "current",
"proprietary_name": "Tribenzor",
"active_ingred_unit": "mg/1; mg/1; mg/1",
"application_number": "NDA200175",
"marketing_category": "NDA",
"nonproprietary_name": "olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide",
"start_marketing_date": "20220901",
"active_numerator_strength": "10; 25; 40"
}Related drugs
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