Gilotrif

Orange BookUNIISPLATC L01EB03

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

Identification

ManufacturerBoehringer Ingelheim Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeL01EB03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0597014130
1 BOTTLE in 1 CARTON (0597-0141-30) / 30 TABLET, FILM COATED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

41UD74L59M

AFATINIB

RxCUI 1430438

Orange Book

N201292

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "41UD74L59M",
    "rxcui": "1430438",
    "inchikey": "ULXXDDBFHOBEHA-CWDCEQMOSA-N",
    "display_name": "AFATINIB",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "fd638e5e-8032-e7ca-0179-95e96ab5d387": {
      "match": "brand_token",
      "title": "GILOTRIF (AFATINIB) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]",
      "spl_version": "20",
      "published_date": "2025-11-19"
    }
  },
  "productid": "0597-0141_3a365319-7ba8-4454-8239-7b0e7ff8a18e",
  "productndc": "0597-0141",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "201292",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 20MG BASE",
        "product_no": "001",
        "approval_date": "Jul 12, 2013"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 30MG BASE",
        "product_no": "002",
        "approval_date": "Jul 12, 2013"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 40MG BASE",
        "product_no": "003",
        "approval_date": "Jul 12, 2013"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AFATINIB",
  "proprietary_name": "Gilotrif",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA201292",
  "marketing_category": "NDA",
  "nonproprietary_name": "afatinib",
  "start_marketing_date": "20130712",
  "active_numerator_strength": "20"
}

Related drugs

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