NDC 50419-252-01 Adempas

Riociguat

NDC Package Code 50419-252-01

The NDC Code 50419-252-01 is assigned to a package of 90 tablet, film coated in 1 bottle of Adempas, a human prescription drug labeled by Bayer Healthcare Pharmaceuticals Inc.. The product's dosage form is tablet, film coated and is administered via oral form.

Field Name Field Value
NDC Code 50419-252-01
Package Description 90 TABLET, FILM COATED in 1 BOTTLE
Proprietary Name Adempas 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 Riociguat 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 Riociguat is used to treat high blood pressure in the lungs (pulmonary hypertension). It can also be used to treat a certain type of high blood pressure in the lungs caused by blood clots (chronic thromboembolic pulmonary hypertension) when surgery has not been fully successful or is impossible. Riociguat works by relaxing and widening the blood vessels in your lungs so blood can flow more easily. Decreasing high blood pressure in the lungs allows your heart and lungs to work better and improves your ability to exercise.
11-Digit NDC Billing Format 50419025201 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 Crosswalk1439821, 1439823, 1439831, 1439833, 1439837, 1439894, 1439896, 1439899, 1439901 and 1439903 - RxCUIs 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 Bayer Healthcare Pharmaceuticals Inc.
Dosage Form Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route(s)
  • Oral - Administration to or by way of the mouth.
Active Ingredient(s)
  • RIOCIGUAT 1.5 mg/1
Pharmacological Class(es)
  • Guanylate Cyclase Stimulators - [MoA] (Mechanism of Action)
  • Soluble Guanylate Cyclase Stimulator - [EPC] (Established Pharmacologic Class)
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 NDA204819 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 10-08-2013 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 12-31-2021 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

  • 50419 - Bayer Healthcare Pharmaceuticals Inc.
    • 50419-252 - Adempas
      • 50419-252-01 - 90 TABLET, FILM COATED in 1 BOTTLE

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 Adempas with product NDC 50419-252.

NDC Package CodePackage Description
50419-252-032 BLISTER PACK in 1 PACKAGE > 21 TABLET, FILM COATED in 1 BLISTER PACK
50419-252-919 TABLET, FILM COATED in 1 BOTTLE

* Please review the disclaimer below.