NDC 50419-325 Gadavist

Gadobutrol Injection Intravenous - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
50419-325
Proprietary Name:
Gadavist
Non-Proprietary Name: [1]
Gadobutrol
Substance Name: [2]
Gadobutrol
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route(s): [4]
  • 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.
  • Labeler Name: [5]
    Bayer Healthcare Pharmaceuticals Inc.
    Labeler Code:
    50419
    FDA Application Number: [6]
    NDA201277
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    03-14-2011
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Packages

    NDC Code 50419-325-11

    Package Description: 2 CARTON in 1 BOX / 10 VIAL, SINGLE-DOSE in 1 CARTON / 7.5 mL in 1 VIAL, SINGLE-DOSE

    NDC Code 50419-325-12

    Package Description: 2 CARTON in 1 BOX / 10 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE

    NDC Code 50419-325-13

    Package Description: 2 CARTON in 1 BOX / 10 VIAL, SINGLE-DOSE in 1 CARTON / 15 mL in 1 VIAL, SINGLE-DOSE

    NDC Code 50419-325-14

    Package Description: 2 CARTON in 1 BOX / 5 BOTTLE, GLASS in 1 CARTON / 30 mL in 1 BOTTLE, GLASS

    NDC Code 50419-325-15

    Package Description: 10 BOTTLE, GLASS in 1 BOX / 65 mL in 1 BOTTLE, GLASS

    NDC Code 50419-325-18

    Package Description: 2 CARTON in 1 BOX / 5 BOTTLE, GLASS in 1 CARTON / 30 mL in 1 BOTTLE, GLASS

    NDC Code 50419-325-19

    Package Description: 10 BOTTLE, GLASS in 1 BOX / 65 mL in 1 BOTTLE, GLASS

    NDC Code 50419-325-27

    Package Description: 5 SYRINGE, GLASS in 1 BOX / 7.5 mL in 1 SYRINGE, GLASS

    NDC Code 50419-325-28

    Package Description: 5 SYRINGE, GLASS in 1 BOX / 10 mL in 1 SYRINGE, GLASS

    NDC Code 50419-325-29

    Package Description: 5 SYRINGE, GLASS in 1 BOX / 15 mL in 1 SYRINGE, GLASS

    NDC Code 50419-325-37

    Package Description: 15 CARTON in 1 BOX / 3 VIAL, SINGLE-DOSE in 1 CARTON / 2 mL in 1 VIAL, SINGLE-DOSE

    NDC Code 50419-325-72

    Package Description: 10 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE

    NDC Code 50419-325-73

    Package Description: 30 mL in 1 BOTTLE, GLASS

    NDC Code 50419-325-74

    Package Description: 65 mL in 1 BOTTLE, GLASS

    NDC Code 50419-325-75

    Package Description: 5 SYRINGE, GLASS in 1 BOX / 10 mL in 1 SYRINGE, GLASS

    Product Details

    What is NDC 50419-325?

    The NDC code 50419-325 is assigned by the FDA to the product Gadavist which is a human prescription drug product labeled by Bayer Healthcare Pharmaceuticals Inc.. The generic name of Gadavist is gadobutrol. The product's dosage form is injection and is administered via intravenous form. The product is distributed in 15 packages with assigned NDC codes 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, 50419-325-14 2 carton in 1 box / 5 bottle, glass in 1 carton / 30 ml in 1 bottle, glass, 50419-325-15 10 bottle, glass in 1 box / 65 ml in 1 bottle, glass, 50419-325-18 2 carton in 1 box / 5 bottle, glass in 1 carton / 30 ml in 1 bottle, glass, 50419-325-19 10 bottle, glass in 1 box / 65 ml in 1 bottle, glass, 50419-325-27 5 syringe, glass in 1 box / 7.5 ml in 1 syringe, glass, 50419-325-28 5 syringe, glass in 1 box / 10 ml in 1 syringe, glass, 50419-325-29 5 syringe, glass in 1 box / 15 ml in 1 syringe, glass, 50419-325-37 15 carton in 1 box / 3 vial, single-dose in 1 carton / 2 ml in 1 vial, single-dose, 50419-325-72 10 vial, single-dose in 1 carton / 10 ml in 1 vial, single-dose, 50419-325-73 30 ml in 1 bottle, glass , 50419-325-74 65 ml in 1 bottle, glass , 50419-325-75 5 syringe, glass in 1 box / 10 ml in 1 syringe, glass. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Gadavist?

    Gadavist is contraindicated in patients with history of severe hypersensitivity reactions to Gadavist.

    What are Gadavist Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    Which are Gadavist UNII Codes?

    The UNII codes for the active ingredients in this product are:

    Which are Gadavist Inactive Ingredients UNII Codes?

    The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

    * Please review the disclaimer below.

    Product Footnotes

    [1] 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.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] 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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] 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.

    [8] 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.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] 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.

    [12] 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".