Telmisartan

Orange BookUNIISPLATC C09CA07

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerJubilant Cadista Pharmacuticals Inc.

CountryUS (United States)

ATC codeC09CA07

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5974644132
3 BLISTER PACK in 1 CARTON (59746-441-32) / 10 TABLET in 1 BLISTER PACK (59746-441-12)

Annotations

UNII (FDA Substance ID)

U5SYW473RQ

TELMISARTAN

RxCUI 73494

Orange Book

A204164

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": "59746-441_482ba8bc-d601-48d8-9d50-8fa4d2c255fe",
  "productndc": "59746-441",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "204164",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "001",
        "approval_date": "Aug 22, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "002",
        "approval_date": "Aug 22, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "80MG",
        "product_no": "003",
        "approval_date": "Aug 22, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TELMISARTAN",
  "proprietary_name": "Telmisartan",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA204164",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Telmisartan",
  "start_marketing_date": "20160822",
  "active_numerator_strength": "80"
}

Related drugs

Other records sharing ATC code C09CA07.

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