Micardis HCT

In shortageOrange BookUNIISPLATC C03AA

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

Identification

ManufacturerBoehringer Ingelheim Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeC03AA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0597004337
3 BLISTER PACK in 1 CARTON (0597-0043-37) / 10 TABLET in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

0J48LPH2TH

HYDROCHLOROTHIAZIDE

RxCUI 5487

Orange Book

N021162

ABABAB

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Hydrochlorothiazide; Quinapril Hydrochloride Tablet

Raw payload (JSON)

{
  "unii": {
    "unii": "0J48LPH2TH",
    "rxcui": "5487",
    "inchikey": "JZUFKLXOESDKRF-UHFFFAOYSA-N",
    "display_name": "HYDROCHLOROTHIAZIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "cfb9309f-e0df-4a55-9542-0e869fce05fb": {
      "match": "brand_token",
      "title": "MICARDIS (TELMISARTAN) TABLET [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]",
      "spl_version": "31",
      "published_date": "2025-05-23"
    }
  },
  "productid": "0597-0043_ea1ff12a-df9e-477b-9e91-f89381987c6d",
  "productndc": "0597-0043",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "021162",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "12.5MG;40MG",
        "product_no": "001",
        "approval_date": "Nov 17, 2000"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "12.5MG;80MG",
        "product_no": "002",
        "approval_date": "Nov 17, 2000"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "25MG;80MG",
        "product_no": "003",
        "approval_date": "Apr 19, 2004"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HYDROCHLOROTHIAZIDE; TELMISARTAN",
  "shortage_reason": "Hydrochlorothiazide; Quinapril Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "Micardis HCT",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA021162",
  "marketing_category": "NDA",
  "nonproprietary_name": "telmisartan and hydrochlorothiazide",
  "start_marketing_date": "20001201",
  "active_numerator_strength": "12.5; 40"
}

Related drugs

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