ESBRIET

Orange BookUNIISPLATC L04AX05

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

Identification

ManufacturerLegacy Pharma USA Inc.

CountryUS (United States)

ATC codeL04AX05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
8310702827
1 BOTTLE, PLASTIC in 1 CARTON (83107-028-27) / 270 TABLET, COATED in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)

D7NLD2JX7U

PIRFENIDONE

RxCUI 1592254

Orange Book

N208780

ABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "D7NLD2JX7U",
    "rxcui": "1592254",
    "inchikey": "ISWRGOKTTBVCFA-UHFFFAOYSA-N",
    "display_name": "PIRFENIDONE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "2e8c3537-36d7-4de5-9b5c-7a624b9a9e6e": {
      "match": "brand_token",
      "title": "ESBRIET (PIRFENIDONE) CAPSULE ESBRIET (PIRFENIDONE) TABLET, COATED [GENENTECH, INC.]",
      "spl_version": "21",
      "published_date": "2025-12-18"
    }
  },
  "productid": "83107-028_372827fa-ccfe-42b6-e063-6394a90af5e8",
  "productndc": "83107-028",
  "dosage_form": "TABLET, COATED",
  "orange_book": {
    "appl_no": "208780",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "267MG",
        "product_no": "001",
        "approval_date": "Jan 11, 2017"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "002",
        "approval_date": "Jan 11, 2017"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "801MG",
        "product_no": "003",
        "approval_date": "Jan 11, 2017"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PIRFENIDONE",
  "proprietary_name": "ESBRIET",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA208780",
  "marketing_category": "NDA",
  "nonproprietary_name": "PIRFENIDONE",
  "start_marketing_date": "20250531",
  "active_numerator_strength": "267"
}

Related drugs

Other records sharing ATC code L04AX05.

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