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United States · US · US:42571-226_f2aa8284-f86c-3425-e053-2995a90a6dc6

TELMISARTAN

Orange BookUNIISPLATC C09CA07

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

Identification

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

Packs · 6

  • ndc11
    4257122605
    500 TABLET in 1 BOTTLE (42571-226-05)
  • ndc11
    4257122610
    1000 TABLET in 1 BOTTLE (42571-226-10)
  • ndc11
    4257122611
    10 BLISTER PACK in 1 CARTON (42571-226-11) / 10 TABLET in 1 BLISTER PACK (42571-226-32)
  • ndc11
    4257122630
    30 TABLET in 1 BOTTLE (42571-226-30)
  • ndc11
    4257122641
    3 TABLET in 1 CARTON (42571-226-41)
  • ndc11
    4257122690
    90 TABLET in 1 BOTTLE (42571-226-90)

Annotations

UNII (FDA Substance ID)
U5SYW473RQ
TELMISARTAN
RxCUI 73494
Orange Book
A207016
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": "42571-226_f2aa8284-f86c-3425-e053-2995a90a6dc6",
  "productndc": "42571-226",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "207016",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "001",
        "approval_date": "Oct 3, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "002",
        "approval_date": "Oct 3, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "80MG",
        "product_no": "003",
        "approval_date": "Oct 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": "ANDA207016",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Telmisartan",
  "start_marketing_date": "20180101",
  "active_numerator_strength": "20"
}

Related drugs

Other records sharing ATC code C09CA07.

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