Letairis

Orange BookUNIISPLATC C02KX02

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

Identification

ManufacturerGilead Sciences, Inc.

CountryUS (United States)

ATC codeC02KX02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
6195808021
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-0802-1)
ndc11
6195808022
3 BLISTER PACK in 1 CARTON (61958-0802-2) / 10 TABLET, FILM COATED in 1 BLISTER PACK
ndc11
6195808023
1 BLISTER PACK in 1 CARTON (61958-0802-3) / 10 TABLET, FILM COATED in 1 BLISTER PACK
ndc11
6195808025
10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-0802-5)

Annotations

UNII (FDA Substance ID)

HW6NV07QEC

AMBRISENTAN

RxCUI 358274

Orange Book

N022081

ABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "HW6NV07QEC",
    "rxcui": "358274",
    "inchikey": "OUJTZYPIHDYQMC-LJQANCHMSA-N",
    "display_name": "AMBRISENTAN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "725d4e73-6c83-477a-adc6-0ae4a133a844": {
      "match": "brand_token",
      "title": "LETAIRIS (AMBRISENTAN) TABLET, FILM COATED [GILEAD SCIENCES, INC.]",
      "spl_version": "27",
      "published_date": "2025-08-28"
    }
  },
  "productid": "61958-0802_273ba426-0edb-47a2-b5d3-883cd1b9369a",
  "productndc": "61958-0802",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "022081",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Jun 15, 2007"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Jun 15, 2007"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMBRISENTAN",
  "proprietary_name": "Letairis",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA022081",
  "marketing_category": "NDA",
  "nonproprietary_name": "AMBRISENTAN",
  "start_marketing_date": "20070615",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code C02KX02.

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