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United States · US · US:65862-869_eea7e7a7-9c01-4097-8e5c-ab1ad574acc8

Telmisartan

Orange BookUNIISPLATC C09CA07

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

Identification

ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeC09CA07
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6586286903
    3 BLISTER PACK in 1 CARTON (65862-869-03) / 10 TABLET in 1 BLISTER PACK (65862-869-10)
  • ndc11
    6586286930
    30 TABLET in 1 BOTTLE (65862-869-30)

Annotations

UNII (FDA Substance ID)
U5SYW473RQ
TELMISARTAN
RxCUI 73494
Orange Book
A206511
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": "65862-869_eea7e7a7-9c01-4097-8e5c-ab1ad574acc8",
  "productndc": "65862-869",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "206511",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "001",
        "approval_date": "Sep 3, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "002",
        "approval_date": "Sep 3, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "80MG",
        "product_no": "003",
        "approval_date": "Sep 3, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TELMISARTAN",
  "proprietary_name": "Telmisartan",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA206511",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Telmisartan",
  "start_marketing_date": "20150903",
  "active_numerator_strength": "80"
}

Related drugs

Other records sharing ATC code C09CA07.

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