Telmisartan

Orange BookUNIISPLATC C09CA07

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

Identification

ManufacturerGlenmark Pharmaceuticals Inc., USA

CountryUS (United States)

ATC codeC09CA07

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
6846220001
100 TABLET in 1 BOTTLE (68462-200-01)
ndc11
6846220013
3 BLISTER PACK in 1 CARTON (68462-200-13) / 10 TABLET in 1 BLISTER PACK
ndc11
6846220030
30 TABLET in 1 BOTTLE (68462-200-30)
ndc11
6846220082
5 BLISTER PACK in 1 CARTON (68462-200-82) / 10 TABLET in 1 BLISTER PACK
ndc11
6846220090
90 TABLET in 1 BOTTLE (68462-200-90)

Annotations

UNII (FDA Substance ID)

U5SYW473RQ

TELMISARTAN

RxCUI 73494

Orange Book

A090032

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": "68462-200_7e08eda5-be87-4e09-ae4e-880a18aa7a0b",
  "productndc": "68462-200",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "090032",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "001",
        "approval_date": "Jul 7, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "002",
        "approval_date": "Jul 7, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "80MG",
        "product_no": "003",
        "approval_date": "Jul 7, 2014"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TELMISARTAN",
  "proprietary_name": "Telmisartan",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA090032",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Telmisartan",
  "start_marketing_date": "20140707",
  "active_numerator_strength": "40"
}

Related drugs

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