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United States · US · US:0713-0875_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

  • ndc11
    0713087530
    30 TABLET, FILM COATED in 1 BOTTLE (0713-0875-30)

Annotations

UNII (FDA Substance ID)
864V2Q084H
AMLODIPINE BESYLATE
RxCUI 104416
Orange Book
N200175
ABABABABAB
FDA shortage
Currently in shortage
Amlodipine Besylate; Hydrochlorothiazide; Olmesartan Medoxomil Tablet
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": "0713-0875_004953ba-fe11-03eb-e063-6394a90a638c",
  "productndc": "0713-0875",
  "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; Hydrochlorothiazide; Olmesartan Medoxomil Tablet",
  "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": "5; 12.5; 40"
}

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