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United States · US · US:0597-0040_333f0ca9-928d-45af-92b9-9ea8a4d02f7d

Micardis

Orange BookUNIISPLATC C09CA07

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

Identification

ManufacturerBoehringer Ingelheim Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeC09CA07
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0597004037
    3 BLISTER PACK in 1 CARTON (0597-0040-37) / 10 TABLET in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
U5SYW473RQ
TELMISARTAN
RxCUI 73494
Orange Book
N020850
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "U5SYW473RQ",
    "rxcui": "73494",
    "inchikey": "RMMXLENWKUUMAY-UHFFFAOYSA-N",
    "display_name": "TELMISARTAN",
    "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": "0597-0040_333f0ca9-928d-45af-92b9-9ea8a4d02f7d",
  "productndc": "0597-0040",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "020850",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "001",
        "approval_date": "Nov 10, 1998"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "80MG",
        "product_no": "002",
        "approval_date": "Nov 10, 1998"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "20MG",
        "product_no": "003",
        "approval_date": "Apr 4, 2000"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TELMISARTAN",
  "proprietary_name": "Micardis",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA020850",
  "marketing_category": "NDA",
  "nonproprietary_name": "telmisartan",
  "start_marketing_date": "20001201",
  "active_numerator_strength": "40"
}

Related drugs

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