NDC 0078-0698-99 Rydapt

Rydapt

NDC Package Code 0078-0698-99

The NDC 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.

Field Name Field Value
NDC 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)
Proprietary Name Rydapt What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Rydapt What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Drug Uses 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 NDC Format for Billing
For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.
Billing Unit EA - Billing unit of "each" is used when the product is dispensed in discreet units.
RxNorm Crosswalk1919088 - RxCUI What is RxNorm?
The RxNorm crosswalk provides a normalized naming system for generic and branded drugs by assigning unique concept identifiers (RxCUI) to each NDC.
Product Type Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
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
Pharmacological Class(es)
  • Kinase Inhibitor - [EPC] (Established Pharmacologic Class)
  • Receptor Tyrosine Kinase Inhibitors - [MoA] (Mechanism of Action)
Sample Package No Sample Package?
This field Indicates whether this package is a sample packaging or not.
Marketing Category NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number NDA207997 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Start Marketing Date 04-28-2017 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
Listing Expiration Date 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
Exclude Flag N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

NDC Code Structure

  • 0078 - Novartis Pharmaceuticals Corporation
    • 0078-0698 - Rydapt
      • 0078-0698-99 - 2 CARTON in 1 CARTON

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 Rydapt with product NDC 0078-0698.

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.