ambrisentan

Orange BookUNIISPLATC C02KX02

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

Identification

ManufacturerAurobindo Pharma Limited

CountryUS (United States)

ATC codeC02KX02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5965149530
30 TABLET, FILM COATED in 1 BOTTLE (59651-495-30)

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": "59651-495_a6d48e99-4411-4724-8372-b01692a5dff7",
  "productndc": "59651-495",
  "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": "10"
}

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