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  5. NDC Package Code: 0078-0628-51 Afinitor Disperz

NDC Package 0078-0628-51 Afinitor Disperz

Everolimus Tablet, For Suspension Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. 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:
0078-0628-51
Package Description:
28 BLISTER PACK in 1 CARTON / 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (0078-0628-61)
Product Code:
0078-0628
Proprietary Name:
Afinitor Disperz
Non-Proprietary Name:
Everolimus
Substance Name:
Everolimus
Usage Information:
Everolimus is used to treat various types of cancer (such as kidney, breast, pancreas, lung, stomach/intestinal cancers). Everolimus is also used in people with a certain genetic disorder (tuberous sclerosis complex) to treat certain types of benign tumors in the brain or kidney. It works by slowing or stopping the growth of cancer or tumor cells.
11-Digit NDC Billing Format:
00078062851
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
28 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1119400 - everolimus 7.5 MG Oral Tablet
  • RxCUI: 1119402 - AFINITOR 7.5 MG Oral Tablet
  • RxCUI: 1119402 - everolimus 7.5 MG Oral Tablet [Afinitor]
  • RxCUI: 1119402 - Afinitor 7.5 MG Oral Tablet
  • RxCUI: 1308428 - everolimus 2 MG Tablet for Oral Suspension
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Novartis Pharmaceuticals Corporation
    Dosage Form:
    Tablet, For Suspension - A tablet that forms a suspension when placed in a liquid (formerly referred to as a ‘dispersible tablet’).
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • EVEROLIMUS 5 mg/1
    • Pharmacologic Class(es):
  • Cytochrome P450 2D6 Inhibitors - [MoA] (Mechanism of Action)
  • Cytochrome P450 3A4 Inhibitors - [MoA] (Mechanism of Action)
  • Decreased Immunologic Activity - [PE] (Physiologic Effect)
  • Kinase Inhibitor - [EPC] (Established Pharmacologic Class)
  • Protein Kinase Inhibitors - [MoA] (Mechanism of Action)
  • mTOR Inhibitor Immunosuppressant - [EPC] (Established Pharmacologic Class)
  • mTOR Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA203985
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    08-29-2012
    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 0078-0628-51?

    The NDC Packaged Code 0078-0628-51 is assigned to a package of 28 blister pack in 1 carton / 1 tablet, for suspension in 1 blister pack (0078-0628-61) of Afinitor Disperz, a human prescription drug labeled by Novartis Pharmaceuticals Corporation. The product's dosage form is tablet, for suspension and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 28 billable units per package.

    Is NDC 0078-0628 included in the NDC Directory?

    Yes, Afinitor Disperz with product code 0078-0628 is active and included in the NDC Directory. The product was first marketed by Novartis Pharmaceuticals Corporation on August 29, 2012 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 0078-0628-51?

    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 28.

    What is the 11-digit format for NDC 0078-0628-51?

    The 11-digit format is 00078062851. 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
    4-4-20078-0628-515-4-200078-0628-51