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United States · US · US:67877-483_3176efce-402d-3398-e063-6294a90a2f27

telmisartan

Orange BookUNIISPLATC C09CA07

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

Identification

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

Packs · 3

  • ndc11
    6787748305
    500 TABLET in 1 BOTTLE (67877-483-05)
  • ndc11
    6787748330
    30 TABLET in 1 BOTTLE (67877-483-30)
  • ndc11
    6787748390
    90 TABLET in 1 BOTTLE (67877-483-90)

Annotations

UNII (FDA Substance ID)
U5SYW473RQ
TELMISARTAN
RxCUI 73494
Orange Book
A205150
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": "67877-483_3176efce-402d-3398-e063-6294a90a2f27",
  "productndc": "67877-483",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "205150",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "001",
        "approval_date": "Oct 30, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "002",
        "approval_date": "Oct 30, 2015"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "80MG",
        "product_no": "003",
        "approval_date": "Oct 30, 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": "ANDA205150",
  "marketing_category": "ANDA",
  "nonproprietary_name": "telmisartan",
  "start_marketing_date": "20160612",
  "active_numerator_strength": "40"
}

Related drugs

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