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  5. NDC Package Code: 0078-0698-99 Rydapt

NDC Package 0078-0698-99 Rydapt

Capsule, Liquid Filled 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:
0078-0698-99
Package Description:
2 CARTON in 1 CARTON / 14 BLISTER PACK in 1 CARTON (0078-0698-51) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0078-0698-02)
Product Code:
0078-0698
Proprietary Name:
Rydapt
Non-Proprietary Name:
Rydapt
Substance Name:
Midostaurin
Usage Information:
Midostaurin is used to treat certain types of blood cell cancer (acute myeloid leukemia-AML, mast cell leukemia-MCL) or an immune system disorder (mastocytosis). It works by slowing or stopping the growth of cancer cells and certain immune system cells (mast cells).
11-Digit NDC Billing Format:
00078069899
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
2 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1919088 - midostaurin 25 MG Oral Capsule
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Novartis Pharmaceuticals Corporation
    Dosage Form:
    Capsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • MIDOSTAURIN 25 mg/1
    • Pharmacologic Class(es):
  • Kinase Inhibitor - [EPC] (Established Pharmacologic Class)
  • Receptor Tyrosine Kinase Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA207997
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    04-28-2017
    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
    0078-0698-194 CARTON in 1 CARTON / 14 BLISTER PACK in 1 CARTON (0078-0698-51) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0078-0698-02)

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0078-0698-99?

    The NDC Packaged Code 0078-0698-99 is assigned to a package of 2 carton in 1 carton / 14 blister pack in 1 carton (0078-0698-51) / 2 capsule, liquid filled in 1 blister pack (0078-0698-02) of Rydapt, a human prescription drug labeled by Novartis Pharmaceuticals Corporation. The product's dosage form is capsule, liquid filled and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 2 billable units per package.

    Is NDC 0078-0698 included in the NDC Directory?

    Yes, Rydapt with product code 0078-0698 is active and included in the NDC Directory. The product was first marketed by Novartis Pharmaceuticals Corporation on April 28, 2017 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 NDC billing unit for package 0078-0698-99?

    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 2.

    What is the 11-digit format for NDC 0078-0698-99?

    The 11-digit format is 00078069899. 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
    4-4-20078-0698-995-4-200078-0698-99