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United States · US · US:33342-193_bd687a21-be18-439a-8e65-103a15b4a8f8

AMLODIPINE and OLMESARTAN medoxomil

In shortageOrange BookUNIISPLATC C08CA

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

Identification

ManufacturerMacleods Pharmaceuticals Limited
CountryUS (United States)
ATC codeC08CA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    3334219307
    30 TABLET, FILM COATED in 1 BOTTLE (33342-193-07)
  • ndc11
    3334219310
    90 TABLET, FILM COATED in 1 BOTTLE (33342-193-10)
  • ndc11
    3334219312
    10 BLISTER PACK in 1 CARTON (33342-193-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • ndc11
    3334219344
    1000 TABLET, FILM COATED in 1 BOTTLE (33342-193-44)

Annotations

UNII (FDA Substance ID)
864V2Q084H
AMLODIPINE BESYLATE
RxCUI 104416
Orange Book
A206884
ABABABAB
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": {
    "6efc0ef6-0424-44fc-a9ea-eb30c3b83239": {
      "match": "brand_token",
      "title": "AMLODIPINE BESYLATE TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]",
      "spl_version": "1",
      "published_date": "2026-06-01"
    }
  },
  "productid": "33342-193_bd687a21-be18-439a-8e65-103a15b4a8f8",
  "productndc": "33342-193",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "206884",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE;20MG",
        "product_no": "001",
        "approval_date": "Oct 26, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE;20MG",
        "product_no": "002",
        "approval_date": "Oct 26, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE;40MG",
        "product_no": "003",
        "approval_date": "Oct 26, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE;40MG",
        "product_no": "004",
        "approval_date": "Oct 26, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL",
  "shortage_reason": "Amlodipine Besylate; Hydrochlorothiazide; Olmesartan Medoxomil Tablet",
  "shortage_status": "current",
  "proprietary_name": "AMLODIPINE and OLMESARTAN medoxomil",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA206884",
  "marketing_category": "ANDA",
  "nonproprietary_name": "AMLODIPINE and OLMESARTAN medoxomil",
  "start_marketing_date": "20161027",
  "active_numerator_strength": "10; 40"
}

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