ambrisentan

Orange BookUNIISPLATC C02KX02

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

Identification

ManufacturerA-S Medication Solutions

CountryUS (United States)

ATC codeC02KX02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5009076710
30 TABLET, FILM COATED in 1 BOTTLE (50090-7671-0)

Annotations

UNII (FDA Substance ID)

HW6NV07QEC

AMBRISENTAN

RxCUI 358274

Orange Book

A216531

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": "50090-7671_364758a6-9e0a-4ef9-8019-4bc320bdc9b8",
  "productndc": "50090-7671",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "216531",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Jul 21, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Jul 21, 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": "ANDA216531",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ambrisentan",
  "start_marketing_date": "20220721",
  "active_numerator_strength": "5"
}

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