olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide

In shortageOrange BookUNIISPLATC C08CA

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeC08CA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6362922381
30 TABLET, FILM COATED in 1 BOTTLE (63629-2238-1)

Annotations

UNII (FDA Substance ID)

864V2Q084H

AMLODIPINE BESYLATE

RxCUI 104416

Orange Book

A206137

ABABABABAB

DailyMed SPL labels

1 version tracked

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",
  "spl_meta": {
    "7f78d14a-acf2-4f82-9d20-dfcbd5e9ffb3": {
      "match": "brand_token",
      "title": "OLMESARTAN MEDOXOMIL TABLET [A-S MEDICATION SOLUTIONS]",
      "spl_version": "1",
      "published_date": "2026-06-01"
    }
  },
  "productid": "63629-2238_8def81ed-0ec3-4756-a999-962107b62ef5",
  "productndc": "63629-2238",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "206137",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE;12.5MG;20MG",
        "product_no": "001",
        "approval_date": "Oct 26, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE;12.5MG;40MG",
        "product_no": "002",
        "approval_date": "Oct 26, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE;25MG;40MG",
        "product_no": "003",
        "approval_date": "Oct 26, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE;12.5MG;40MG",
        "product_no": "004",
        "approval_date": "Oct 26, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE;25MG;40MG",
        "product_no": "005",
        "approval_date": "Oct 26, 2016"
      }
    ],
    "appl_type": "A"
  },
  "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": "olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide",
  "active_ingred_unit": "mg/1; mg/1; mg/1",
  "application_number": "ANDA206137",
  "marketing_category": "ANDA",
  "nonproprietary_name": "olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide",
  "start_marketing_date": "20161026",
  "active_numerator_strength": "5; 12.5; 20"
}

Related drugs

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