United States· US:24338-002_d5293244-59c5-44b0-b82b-0f1cf863d8fb

WIDAPLIK

A dihydropyridine derivatives product containing telmisartan, amlodipine and indapamide, registered in United States by Azurity Pharmaceuticals, Inc..

In shortageATC C08CAOrange BookUS label

Checked against FDA National Drug Code directory (United States) on June 3, 2026

Informational only — not a medical device.

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The record

At a glance

FDA National Drug Code directory (United States)

Active substance: telmisartan, amlodipine and indapamide
Manufacturer: Azurity Pharmaceuticals, Inc.
Country: United States (US)
ATC code: C08CA
ATC class: Dihydropyridine derivatives
Reimbursed: Not published by this register
Source register: FDA National Drug Code directory (United States)
Last checked: June 3, 2026

Packs & prices · 1

ndc11
2433800230
30 TABLET in 1 BOTTLE (24338-002-30)

Regulatory notes

UNII (FDA substance ID)

864V2Q084H

AMLODIPINE BESYLATE

RxCUI 104416

Orange Book

N219423

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Amlodipine Besylate; Hydrochlorothiazide; Olmesartan Medoxomil Tablet

Same class

Other records under C08CA

Dihydropyridine derivatives, as other registers publish it.

All telmisartan, amlodipine and indapamide products

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.

For developers

The same record over the API, and the raw payload

GET /v1/drugs/b1d0855b-4604-4842-bef0-670bb7ba4b6a
GET /v1/drugs/b1d0855b-4604-4842-bef0-670bb7ba4b6a?format=fhir

Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.

{
  "unii": {
    "unii": "864V2Q084H",
    "rxcui": "104416",
    "inchikey": "ZPBWCRDSRKPIDG-UHFFFAOYSA-N",
    "display_name": "AMLODIPINE BESYLATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "a30ff81d-420b-40ea-83d8-670260a93fff": {
      "match": "brand_token",
      "title": "WIDAPLIK (TELMISARTAN, AMLODIPINE AND INDAPAMIDE) TABLET [AZURITY PHARMACEUTICALS, INC.]",
      "spl_version": "2",
      "published_date": "2026-04-20"
    }
  },
  "productid": "24338-002_d5293244-59c5-44b0-b82b-0f1cf863d8fb",
  "productndc": "24338-002",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "219423",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 1.25MG BASE;0.625MG;10MG",
        "product_no": "001",
        "approval_date": "Jun 5, 2025"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 2.5MG BASE;1.25MG;20MG",
        "product_no": "002",
        "approval_date": "Jun 5, 2025"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 5MG BASE;2.5MG;40MG",
        "product_no": "003",
        "approval_date": "Jun 5, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMLODIPINE BESYLATE; INDAPAMIDE; TELMISARTAN",
  "shortage_reason": "Amlodipine Besylate; Hydrochlorothiazide; Olmesartan Medoxomil Tablet",
  "shortage_status": "current",
  "proprietary_name": "WIDAPLIK",
  "active_ingred_unit": "mg/1; mg/1; mg/1",
  "application_number": "NDA219423",
  "marketing_category": "NDA",
  "nonproprietary_name": "telmisartan, amlodipine and indapamide",
  "start_marketing_date": "20251020",
  "active_numerator_strength": "2.5; 1.25; 20"
}

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