Ambrisentan

Orange BookUNIISPLATC C02KX02

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

Identification

ManufacturerApotex Corp.

CountryUS (United States)

ATC codeC02KX02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6050545533
30 TABLET, FILM COATED in 1 BOTTLE (60505-4553-3)

Annotations

UNII (FDA Substance ID)

HW6NV07QEC

AMBRISENTAN

RxCUI 358274

Orange Book

A210701

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": {
    "32549c43-f8ff-422c-b42d-ca0877e661cf": {
      "match": "brand_token",
      "title": "AMBRISENTAN TABLET, FILM COATED [ACTAVIS PHARMA, INC.]",
      "spl_version": "19",
      "published_date": "2026-04-09"
    }
  },
  "productid": "60505-4553_9ea6cb4f-0099-f884-4d51-8335310bf1b9",
  "productndc": "60505-4553",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "210701",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "May 19, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "May 19, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMBRISENTAN",
  "proprietary_name": "Ambrisentan",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA210701",
  "marketing_category": "ANDA",
  "nonproprietary_name": "AMBRISENTAN",
  "start_marketing_date": "20220919",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code C02KX02.

Access this data programmatically

Query Ambrisentan and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs