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  5. NDC Package Code: 0597-0137-90 Gilotrif

NDC Package 0597-0137-90 Gilotrif

Afatinib Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
0597-0137-90
Package Description:
1 BOTTLE in 1 CARTON / 30 TABLET, FILM COATED in 1 BOTTLE
Product Code:
0597-0137
Proprietary Name:
Gilotrif
Non-Proprietary Name:
Afatinib
Substance Name:
Afatinib
Usage Information:
Afatinib is used to treat a certain type of lung cancer (non-small cell lung cancer). It belongs to a class of drugs known as kinase inhibitors. It works by slowing or stopping the growth of cancer cells. It binds to a certain protein (epidermal growth factor receptor-EGFR) in some tumors.
11-Digit NDC Billing Format:
00597013790
NDC to RxNorm Crosswalk:
  • RxCUI: 1430446 - afatinib 20 MG Oral Tablet
  • RxCUI: 1430446 - afatinib 20 MG (as afatinib dimaleate 29.56 MG) Oral Tablet
  • RxCUI: 1430449 - Gilotrif 20 MG Oral Tablet
  • RxCUI: 1430449 - afatinib 20 MG Oral Tablet [Gilotrif]
  • RxCUI: 1430449 - Gilotrif 20 MG (as afatinib dimaleate 29.56 MG) Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Boehringer Ingelheim Pharmaceuticals, Inc.
    Dosage Form:
    Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • AFATINIB 30 mg/1
    • Pharmacologic Class(es):
  • Kinase Inhibitor - [EPC] (Established Pharmacologic Class)
  • Protein Kinase Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA201292
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    07-12-2013
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

    * Please review the disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    0597-0137-301 BOTTLE in 1 CARTON / 30 TABLET, FILM COATED in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0597-0137-90?

    The NDC Packaged Code 0597-0137-90 is assigned to a package of 1 bottle in 1 carton / 30 tablet, film coated in 1 bottle of Gilotrif, a human prescription drug labeled by Boehringer Ingelheim Pharmaceuticals, Inc.. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 0597-0137 included in the NDC Directory?

    Yes, Gilotrif with product code 0597-0137 is active and included in the NDC Directory. The product was first marketed by Boehringer Ingelheim Pharmaceuticals, Inc. on July 12, 2013 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 0597-0137-90?

    The 11-digit format is 00597013790. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    4-4-20597-0137-905-4-200597-0137-90