NDC Package 0078-0438-15 Gleevec

View Billable Units, 11-Digit Format, RxNorm

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

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:
0078-0438-15
Package Description:
30 TABLET in 1 BOTTLE
Product Code:
Proprietary Name:
Gleevec
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:
00078043815
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
30 EA
Labeler Name:
Novartis Pharmaceuticals Corporation
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
End Marketing Date:
09-18-2019
Listing Expiration Date:
09-18-2019
Exclude Flag:
D
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.

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NDC HCPCS Crosswalk

This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

NDC 0078-0438-15 HCPCS crosswalk information with package details and bill units information.

NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
00078043815J8999PRESCRIPTION DRUG, ORAL, CHEMOTHERAPEUTIC, NOS1 EA30EA

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 0078-0438-15?

The NDC Packaged Code 0078-0438-15 is assigned to a package of 30 tablet in 1 bottle of Gleevec, labeled by Novartis Pharmaceuticals Corporation. The product's dosage form is and is administered via form.

Is NDC 0078-0438 included in the NDC Directory?

No, Gleevec with product code 0078-0438 is excluded from the NDC Directory because it was discontinued by the manufacturer. 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 September 18, 2019 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 0078-0438-15?

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 30.

What is the 11-digit format for NDC 0078-0438-15?

The 11-digit format is 00078043815. 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
4-4-20078-0438-155-4-200078-0438-15