Ambrisentan

Orange BookUNIISPLATC C02KX02

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

Identification

ManufacturerZydus Lifesciences Limited

CountryUS (United States)

ATC codeC02KX02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
7077113631
100 TABLET, FILM COATED in 1 BOTTLE (70771-1363-1)
ndc11
7077113633
30 TABLET, FILM COATED in 1 BOTTLE (70771-1363-3)
ndc11
7077113637
1 BLISTER PACK in 1 CARTON (70771-1363-7) / 10 TABLET, FILM COATED in 1 BLISTER PACK
ndc11
7077113638
3 BLISTER PACK in 1 CARTON (70771-1363-8) / 10 TABLET, FILM COATED in 1 BLISTER PACK
ndc11
7077113639
90 TABLET, FILM COATED in 1 BOTTLE (70771-1363-9)

Annotations

UNII (FDA Substance ID)

HW6NV07QEC

AMBRISENTAN

RxCUI 358274

Orange Book

A210058

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": "70771-1363_14a85c38-61bf-4621-8e3a-34ab57a15758",
  "productndc": "70771-1363",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "210058",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Mar 28, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Mar 28, 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": "ANDA210058",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ambrisentan",
  "start_marketing_date": "20190412",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code C02KX02.

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