NDC 50419-325-18 Gadavist

Gadobutrol

NDC Package Code 50419-325-18

The NDC Code 50419-325-18 is assigned to a package of 2 carton in 1 box > 5 bottle, glass in 1 carton > 30 ml in 1 bottle, glass of Gadavist, a human prescription drug labeled by Bayer Healthcare Pharmaceuticals Inc.. The product's dosage form is injection and is administered via intravenous form.

Field Name	Field Value
NDC Code	50419-325-18
Package Description	2 CARTON in 1 BOX > 5 BOTTLE, GLASS in 1 CARTON > 30 mL in 1 BOTTLE, GLASS
Proprietary Name	Gadavist 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	Gadobutrol 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	50419032518 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.
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. Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)	GADOBUTROL 604.72 mg/mL GADOBUTROL 604.72 mg/mL GADOBUTROL 604.72 mg/mL
Pharmacological Class(es)	Gadolinium-based Contrast Agent - [EPC] (Established Pharmacologic Class) Magnetic Resonance Contrast Activity - [MoA] (Mechanism of Action) Gadolinium-based Contrast Agent - [EPC] (Established Pharmacologic Class) Magnetic Resonance Contrast Activity - [MoA] (Mechanism of Action) Gadolinium-based Contrast Agent - [EPC] (Established Pharmacologic Class) Magnetic Resonance Contrast Activity - [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	NDA201277 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	03-14-2011 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

50419 - Bayer Healthcare Pharmaceuticals Inc.
- 50419-325 - Gadavist
  - 50419-325-18 - 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 50419-325-18 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
50419032518	A9585	Gadobutrol injection	0.1 ML	30	10	300	3000

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Other Product Packages

The following packages are also available for Gadavist with product NDC 50419-325.

NDC Package Code	Package Description
50419-325-11	2 CARTON in 1 BOX > 10 VIAL, SINGLE-DOSE in 1 CARTON > 7.5 mL in 1 VIAL, SINGLE-DOSE
50419-325-12	2 CARTON in 1 BOX > 10 VIAL, SINGLE-DOSE in 1 CARTON > 10 mL in 1 VIAL, SINGLE-DOSE
50419-325-13	2 CARTON in 1 BOX > 10 VIAL, SINGLE-DOSE in 1 CARTON > 15 mL in 1 VIAL, SINGLE-DOSE