NDC 50419-188-81 Magnevist

Gadopentetate Dimeglumine

NDC Package Code 50419-188-81

The NDC Code 50419-188-81 is assigned to a package of 2 carton in 1 box > 10 vial, single-dose in 1 carton > 5 ml in 1 vial, single-dose of Magnevist, a human prescription drug labeled by Bayer Healthcare Pharmaceuticals Inc.. The product's dosage form is injection and is administered via intravenous form.This product is billed per "ML" milliliter and contains an estimated amount of 100 billable units per package.

Field Name	Field Value
NDC Code	50419-188-81
Package Description	2 CARTON in 1 BOX > 10 VIAL, SINGLE-DOSE in 1 CARTON > 5 mL in 1 VIAL, SINGLE-DOSE
Proprietary Name	Magnevist 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	Gadopentetate Dimeglumine 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.
11-Digit NDC Billing Format	50419018881 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	ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Estimated Billable Units per Package	100 ML
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	Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route(s)	Intravenous - Administration within or into a vein or veins. Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)	GADOPENTETATE DIMEGLUMINE 469.01 mg/mL GADOPENTETATE DIMEGLUMINE 469.01 mg/mL
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	NDA021037 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	12-14-2010 What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
End Marketing Date	05-30-2022 What is the End Marketing Date? This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
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.
- 50419-188 - Magnevist
  - 50419-188-81 - 2 CARTON in 1 BOX

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.

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NDC HCPCS Crosswalk

This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

NDC 50419-188-81 HCPCS crosswalk information with package details and bill units information.

NDC Billing Code	HCPCS Code	HCPCS Code Desc.	Dosage	Package Size	Package Quantity	Billable Units	Billable Units / Pkg
50419018881	A9579	Gad-base mr contrast nos,1ml	1 ML	5	20	5	100

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Other Product Packages

The following packages are also available for Magnevist with product NDC 50419-188.

NDC Package Code	Package Description
50419-188-05	20 CARTON in 1 BOX > 1 VIAL, SINGLE-DOSE in 1 CARTON > 5 mL in 1 VIAL, SINGLE-DOSE
50419-188-11	10 VIAL, PHARMACY BULK PACKAGE in 1 BOX > 100 mL in 1 VIAL, PHARMACY BULK PACKAGE
50419-188-15	20 CARTON in 1 BOX > 1 VIAL, SINGLE-DOSE in 1 CARTON > 15 mL in 1 VIAL, SINGLE-DOSE
50419-188-37	5 SYRINGE in 1 BOX > 15 mL in 1 SYRINGE
50419-188-38	5 SYRINGE in 1 BOX > 20 mL in 1 SYRINGE
50419-188-40	20 CARTON in 1 BOX > 1 VIAL, SINGLE-DOSE in 1 CARTON > 5 mL in 1 VIAL, SINGLE-DOSE
50419-188-44	20 CARTON in 1 BOX > 20 VIAL, SINGLE-DOSE in 1 CARTON > 15 mL in 1 VIAL, SINGLE-DOSE
50419-188-45	5 SYRINGE in 1 BOX > 15 mL in 1 SYRINGE
50419-188-47	5 SYRINGE in 1 BOX > 20 mL in 1 SYRINGE
50419-188-58	10 VIAL, PHARMACY BULK PACKAGE in 1 BOX > 50 mL in 1 VIAL, PHARMACY BULK PACKAGE
50419-188-83	2 CARTON in 1 BOX > 10 VIAL, SINGLE-DOSE in 1 CARTON > 15 mL in 1 VIAL, SINGLE-DOSE

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