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  4. NDC Product Code: 17772-133 Qelbree

NDC 17772-133 Qelbree

Viloxazine Hydrochloride Capsule, Extended Release Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 17772-133?
  5. Qelbree Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes
  11. Patient Education

Product Information

NDC Product Code:
17772-133
Proprietary Name:
Qelbree
Non-Proprietary Name: [1]
Viloxazine Hydrochloride
Substance Name: [2]
Viloxazine Hydrochloride
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Capsule, Extended Release - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin, and which releases a drug (or drugs) in such a manner to allow a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Supernus Pharmaceuticals, Inc
    Labeler Code:
    17772
    Product Label ID:
    aedf408d-0f84-418d-9416-7c39ddb0d29a
    FDA Application Number: [6]
    NDA211964
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    04-02-2021
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    YELLOW (C48330)
    PURPLE (C48327)
    GREEN (C48329)
    Shape:
    CAPSULE (C48336)
    Size(s):
    19 MM
    24 MM
    25 MM
    Imprint(s):
    SPN;100
    SPN;150
    SPN;200
    Score:
    1

    Product Packages

    NDC Code 17772-133-01

    Package Description: 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

    NDC Code 17772-133-07

    Package Description: 7 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

    NDC Code 17772-133-30

    Package Description: 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

    Price per Unit: $11.37192 per EA

    NDC Code 17772-133-60

    Package Description: 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

    Price per Unit: $11.37192 per EA

    NDC Code 17772-133-90

    Package Description: 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

    Product Details

    What is NDC 17772-133?

    The NDC code 17772-133 is assigned by the FDA to the product Qelbree which is a human prescription drug product labeled by Supernus Pharmaceuticals, Inc. The generic name of Qelbree is viloxazine hydrochloride. The product's dosage form is capsule, extended release and is administered via oral form. The product is distributed in 5 packages with assigned NDC codes 17772-133-01 100 capsule, extended release in 1 bottle , 17772-133-07 7 capsule, extended release in 1 bottle , 17772-133-30 30 capsule, extended release in 1 bottle , 17772-133-60 60 capsule, extended release in 1 bottle , 17772-133-90 90 capsule, extended release in 1 bottle . 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 Qelbree?

    Qelbree is indicated for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age.

    What are Qelbree 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 Qelbree UNII Codes?

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

    Which are Qelbree 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:

    What is the NDC to RxNorm Crosswalk for Qelbree?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
    • RxCUI: 2536548 - viloxazine 100 MG 24HR Extended Release Oral Capsule
    • RxCUI: 2536548 - 24 HR viloxazine 100 MG Extended Release Oral Capsule
    • RxCUI: 2536548 - viloxazine 100 MG (as viloxazine HCl 115 MG) 24 HR Extended Release Oral Capsule
    • RxCUI: 2536554 - Qelbree 100 MG 24HR Extended Release Oral Capsule
    • RxCUI: 2536554 - 24 HR viloxazine 100 MG Extended Release Oral Capsule [Qelbree]

    Which are the Pharmacologic Classes for Qelbree?

    * Please review the disclaimer below.

    Patient Education

    Viloxazine


    Viloxazine is used as part of a total treatment program to increase the ability to pay attention and decrease impulsiveness and hyperactivity in children 6 to 17 years of age with attention deficit hyperactivity disorder (ADHD). Viloxazine is in a class of medications called selective norepinephrine reuptake inhibitors. It works by increasing the levels of norepinephrine, a natural substance in the brain that is needed to control behavior.
    [Learn More]


    * 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".