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United States · US · US:42571-236_2b531912-67b1-6172-e063-6394a90a178f

AMLODIPINE AND OLMESARTAN MEDOXOMIL

In shortageOrange BookUNIISPLATC C08CA

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

Identification

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

Packs · 4

  • ndc11
    4257123605
    500 TABLET in 1 BOTTLE (42571-236-05)
  • ndc11
    4257123610
    1000 TABLET in 1 BOTTLE (42571-236-10)
  • ndc11
    4257123630
    30 TABLET in 1 BOTTLE (42571-236-30)
  • ndc11
    4257123690
    90 TABLET in 1 BOTTLE (42571-236-90)

Annotations

UNII (FDA Substance ID)
864V2Q084H
AMLODIPINE BESYLATE
RxCUI 104416
Orange Book
A207435
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": "42571-236_2b531912-67b1-6172-e063-6394a90a178f",
  "productndc": "42571-236",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "207435",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE;20MG",
        "product_no": "001",
        "approval_date": "Nov 2, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE;40MG",
        "product_no": "002",
        "approval_date": "Nov 2, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE;20MG",
        "product_no": "003",
        "approval_date": "Nov 2, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE;40MG",
        "product_no": "004",
        "approval_date": "Nov 2, 2017"
      }
    ],
    "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": "ANDA207435",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Amlodipine and Olmesartan Medoxomil",
  "start_marketing_date": "20180101",
  "active_numerator_strength": "10; 20"
}

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