OLMESARTAN MEDOXOMIL, AMLODIPINE and HYDROCHLOROTHIAZIDE

In shortageOrange BookUNIISPLATC C08CA

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

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
4257124905
500 TABLET, FILM COATED in 1 BOTTLE (42571-249-05)
ndc11
4257124910
1000 TABLET, FILM COATED in 1 BOTTLE (42571-249-10)
ndc11
4257124930
30 TABLET, FILM COATED in 1 BOTTLE (42571-249-30)
ndc11
4257124990
90 TABLET, FILM COATED in 1 BOTTLE (42571-249-90)

Annotations

UNII (FDA Substance ID)

864V2Q084H

AMLODIPINE BESYLATE

RxCUI 104416

Orange Book

A207437

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": "42571-249_44b62ded-18e8-b2e8-e063-6294a90ac180",
  "productndc": "42571-249",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "207437",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE;12.5MG;20MG",
        "product_no": "001",
        "approval_date": "Nov 24, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE;12.5MG;40MG",
        "product_no": "002",
        "approval_date": "Nov 24, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE;25MG;40MG",
        "product_no": "003",
        "approval_date": "Nov 24, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE;12.5MG;40MG",
        "product_no": "004",
        "approval_date": "Nov 24, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE;25MG;40MG",
        "product_no": "005",
        "approval_date": "Nov 24, 2025"
      }
    ],
    "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 and HYDROCHLOROTHIAZIDE",
  "active_ingred_unit": "mg/1; mg/1; mg/1",
  "application_number": "ANDA207437",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Olmesartan Medoxomil, Amlodipine besylate and Hydrochlorothiazide",
  "start_marketing_date": "20260301",
  "active_numerator_strength": "10; 25; 40"
}

Related drugs

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