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United States · US · US:43547-284_98f95e17-f88b-4f47-b4bb-5db8f93793f7

Telmisartan

Orange BookUNIISPLATC C09CA07

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

Identification

ManufacturerSolco Healthcare US, LLC
CountryUS (United States)
ATC codeC09CA07
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    4354728403
    30 TABLET in 1 BOTTLE (43547-284-03)
  • ndc11
    4354728409
    90 TABLET in 1 BOTTLE (43547-284-09)
  • ndc11
    4354728450
    500 TABLET in 1 BOTTLE (43547-284-50)

Annotations

UNII (FDA Substance ID)
U5SYW473RQ
TELMISARTAN
RxCUI 73494
Orange Book
A207882
ABABAB
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": {
    "a5ded796-3555-4476-8b37-0cdc88d7594a": {
      "match": "brand_token",
      "title": "TELMISARTAN TABLET [BRYANT RANCH PREPACK]",
      "spl_version": "102",
      "published_date": "2026-05-25"
    }
  },
  "productid": "43547-284_98f95e17-f88b-4f47-b4bb-5db8f93793f7",
  "productndc": "43547-284",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "207882",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "001",
        "approval_date": "May 3, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "002",
        "approval_date": "May 3, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "80MG",
        "product_no": "003",
        "approval_date": "May 3, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TELMISARTAN",
  "proprietary_name": "Telmisartan",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA207882",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Telmisartan",
  "start_marketing_date": "20170820",
  "active_numerator_strength": "40"
}

Related drugs

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