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NDC 17772-0131-07 QELBREE 100 mg/1 Details
QELBREE 100 mg/1
QELBREE is a ORAL CAPSULE, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Supernus Pharmaceuticals, Inc. The primary component is VILOXAZINE HYDROCHLORIDE.
MedlinePlus Drug Summary
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.
Related Packages: 17772-0131-07Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Viloxazine
Product Information
| NDC | 17772-0131 |
|---|---|
| Product ID | 17772-131_0cf4dfd5-09e2-4829-e063-6294a90afbfc |
| Associated GPIs | 61354080207020 |
| GCN Sequence Number | 082132 |
| GCN Sequence Number Description | viloxazine HCl CAP ER 24H 100 MG ORAL |
| HIC3 | H7Y |
| HIC3 Description | TX FOR ATTENTION DEFICIT-HYPERACT.(ADHD), NRI-TYPE |
| GCN | 49447 |
| HICL Sequence Number | 007345 |
| HICL Sequence Number Description | VILOXAZINE HCL |
| Brand/Generic | Brand |
| Proprietary Name | QELBREE |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | viloxazine hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 100 |
| Active Ingredient Units | mg/1 |
| Substance Name | VILOXAZINE HYDROCHLORIDE |
| Labeler Name | Supernus Pharmaceuticals, Inc |
| Pharmaceutical Class | Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2B6 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA211964 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 17772-0131-07 (17772013107)
| NDC Package Code | 17772-131-07 |
|---|---|
| Billing NDC | 17772013107 |
| Package | 7 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-131-07) |
| Marketing Start Date | 2021-04-02 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |