Rydapt Capsule, Liquid Filled
NDC Package 0078-0698-99

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Rydapt capsules is 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). This formulation utilizes a capsule, liquid filled delivery system. Marketed by Novartis Pharmaceuticals Corporation, this product is identified by NDC 0078-0698 and is authorized under FDA application NDA207997.

Identification & Billing

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
11-Digit Billing Format
00078069899
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
2 EA
RxNorm Crosswalk
RxCUI: 1919088 - midostaurin 25 MG Oral Capsule

Clinical Specifications

Proprietary Name
Rydapt
Non-Proprietary Name
Rydapt
Substance Name
Midostaurin
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
MIDOSTAURIN 25 mg/1
Pharmacologic Class
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).

Regulatory & Marketing

Labeler Name
Novartis Pharmaceuticals Corporation
Product Type
Human Prescription Drug
FDA Application #
NDA207997
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-28-2017
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0078-0698). Click a package code to view its specific billing and regulatory data.

0078-0698-19
4 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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0078-0698-99 identifies a specific commercial 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. This product is billed for "EA" each discreet unit and contains an estimated amount of 2 billable units per package. This capsule, liquid filled is formulated for oral use and contains midostaurin as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Novartis Pharmaceuticals Corporation on April 28, 2017. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

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).

How is this Novartis Pharmaceuticals Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00078069899. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 2 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (4-4-2)
0078-0698-99
11-Digit CMS (5-4-2)
00078-0698-99

Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.