AMBRISENTAN

Orange BookUNIISPLATC C02KX02

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

Identification

ManufacturerSigmapharm Laboratories, LLC

CountryUS (United States)

ATC codeC02KX02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
4279405108
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42794-051-08)
ndc11
4279405122
10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42794-051-22)

Annotations

UNII (FDA Substance ID)

HW6NV07QEC

AMBRISENTAN

RxCUI 358274

Orange Book

A208354

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": "42794-051_f1f20771-a78f-74cf-e053-2995a90a6adf",
  "productndc": "42794-051",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "208354",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Apr 10, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Apr 10, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMBRISENTAN",
  "proprietary_name": "AMBRISENTAN",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA208354",
  "marketing_category": "ANDA",
  "nonproprietary_name": "AMBRISENTAN",
  "start_marketing_date": "20190410",
  "active_numerator_strength": "5"
}

Related drugs

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