NDC Package 0078-0401-34 Gleevec

Imatinib Mesylate Tablet Oral - View Billable Units, 11-Digit Format, RxNorm

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:
0078-0401-34
Package Description:
90 TABLET in 1 BOTTLE
Product Code:
Proprietary Name:
Gleevec
Non-Proprietary Name:
Imatinib Mesylate
Substance Name:
Imatinib Mesylate
Usage Information:
This medication is used to treat certain types of cancer (such as acute lymphoblastic leukemia, chronic myeloid leukemia, gastrointestinal stromal tumors, and myelodysplastic/myeloproliferative diseases). It works by slowing or stopping the growth of cancer cells. Imatinib may also be used to treat certain immune system disorders (such as aggressive systemic mastocytosis, hypereosinophilic syndrome).
11-Digit NDC Billing Format:
00078040134
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
90 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 403878 - imatinib mesylate 100 MG Oral Tablet
  • RxCUI: 403878 - imatinib 100 MG Oral Tablet
  • RxCUI: 403878 - imatinib 100 MG (as imatinib mesylate) Oral Tablet
  • RxCUI: 403879 - imatinib mesylate 400 MG Oral Tablet
  • RxCUI: 403879 - imatinib 400 MG Oral Tablet
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Novartis Pharmaceuticals Corporation
    Dosage Form:
    Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
  • Active Ingredient(s):
    Sample Package:
    No
    FDA Application Number:
    NDA021588
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    05-15-2001
    Listing Expiration Date:
    12-31-2025
    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.

    Frequently Asked Questions

    What is NDC 0078-0401-34?

    The NDC Packaged Code 0078-0401-34 is assigned to a package of 90 tablet in 1 bottle of Gleevec, a human prescription drug labeled by Novartis Pharmaceuticals Corporation. The product's dosage form is tablet and is administered via oral form.

    Is NDC 0078-0401 included in the NDC Directory?

    Yes, Gleevec with product code 0078-0401 is active and included in the NDC Directory. The product was first marketed by Novartis Pharmaceuticals Corporation on May 15, 2001 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 0078-0401-34?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 90.

    What is the 11-digit format for NDC 0078-0401-34?

    The 11-digit format is 00078040134. 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
    4-4-20078-0401-345-4-200078-0401-34