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United States · US · US:49884-789_9ce53e8f-235a-4ebc-b1b1-4e764daacab2

olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide

In shortageOrange BookUNIISPLATC C08CA

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerPar Health USA, LLC
CountryUS (United States)
ATC codeC08CA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    4988478909
    90 TABLET, FILM COATED in 1 BOTTLE (49884-789-09)
  • ndc11
    4988478911
    30 TABLET, FILM COATED in 1 BOTTLE (49884-789-11)

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; 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",
  "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": "49884-789_9ce53e8f-235a-4ebc-b1b1-4e764daacab2",
  "productndc": "49884-789",
  "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; Hydrochlorothiazide; Olmesartan Medoxomil Tablet",
  "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": "10; 12.5; 40"
}

Related drugs

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