OpenRx Open Medications Explorer
© 2026 OpenRx · public-domain U.S. government data
On this page

QELBREE

viloxazine hydrochloride · Capsule, Extended Release

Prescription NDA RLD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information.

Overview

Brand name
QELBREE
Generic name
viloxazine hydrochloride
Dosage form
Capsule, Extended Release
Route
Oral
Marketing category
NDA · NDA
Labeler
Supernus Pharmaceuticals, Inc
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
3
NDC product codes
3
Packages
15
Data completeness
54% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Viloxazine Hydrochloride 100 mg/1 — —
Viloxazine Hydrochloride 150 mg/1 — —
Viloxazine Hydrochloride 200 mg/1 — —

Forms, strengths and routes

Source: NDC Directory
Dosage form
Capsule, Extended Release
Route of administration
Oral
Presentations
18

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Cytochrome P450 1A2 Inhibitors [MoA] MoA All 31 members
Cytochrome P450 2B6 Inhibitors [MoA] MoA 4 members — no class page
Cytochrome P450 2D6 Inhibitors [MoA] MoA All 72 members
Cytochrome P450 3A4 Inhibitors [MoA] MoA All 118 members
Norepinephrine Reuptake Inhibitor [EPC] EPC 4 members — no class page
Norepinephrine Uptake Inhibitors [MoA] MoA All 44 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
211964
Application type
NDA · New Drug Application
Approval date
April 2, 2021
Sponsor
SUPERNUS PHARMS
Products on application
3
Submissions recorded
3
Products approved under application 211964.
Product Trade name Form Strength Ingredient Status TE Flags
211964-001 QELBREE CAPSULE, EXTENDED RELEASE VILOXAZINE HYDROCHLORIDE Prescription — RLD
211964-002 QELBREE CAPSULE, EXTENDED RELEASE VILOXAZINE HYDROCHLORIDE Prescription — RLD
211964-003 QELBREE CAPSULE, EXTENDED RELEASE VILOXAZINE HYDROCHLORIDE Prescription — RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Patents and exclusivity

Source: Orange Book
Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent Expires Product Substance Use code Submitted
12121523 September 4, 2029 001 No U-727 November 21, 2024
11458143 September 4, 2029 001 No U-727 October 7, 2022
11324753 September 4, 2029 001 No U-727 May 17, 2022
12121523 September 4, 2029 002 No U-727 November 21, 2024
11458143 September 4, 2029 002 No U-727 October 7, 2022
11324753 September 4, 2029 002 No U-727 May 17, 2022
12121523 September 4, 2029 003 No U-727 November 21, 2024
11458143 September 4, 2029 003 No U-727 October 7, 2022
11324753 September 4, 2029 003 No U-727 May 17, 2022
9603853 February 7, 2033 001 No U-727 April 29, 2021
9358204 February 7, 2033 001 No April 29, 2021
9603853 February 7, 2033 002 No U-727 April 29, 2021
9358204 February 7, 2033 002 No April 29, 2021
9603853 February 7, 2033 003 No U-727 April 29, 2021
9358204 February 7, 2033 003 No April 29, 2021
9662338 April 2, 2035 001 No April 29, 2021
9662338 April 2, 2035 002 No April 29, 2021
9662338 April 2, 2035 003 No April 29, 2021
Regulatory exclusivity periods.
Code Expires Product
NCE April 2, 2026 001
NCE April 2, 2026 002
NCE April 2, 2026 003

Approval history

Source: Drugs@FDA
Most recent submissions on application 211964.
Type No. Action Status Date Review
Supplement 13 Labeling Approved January 23, 2025 Standard
Supplement 3 Efficacy Approved April 29, 2022 Standard
Original application 1 Type 1 - New Molecular Entity Approved April 2, 2021 Standard

Review documents

  • 0 · Supplement · February 6, 2025
  • 0 · Supplement · February 6, 2025
  • 0 · Supplement · February 6, 2025
  • 0 · Supplement · February 6, 2025
  • 0 · Supplement · May 3, 2022
  • 0 · Supplement · May 2, 2022
  • 0 · Original application · May 3, 2021
  • 0 · Original application · April 5, 2021
  • 0 · Original application · April 2, 2021

Adverse event reports

Source: openFDA FAERS
0
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
17772-131-01 17772-131 Supernus Pharmaceuticals, Inc 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-131-01) April 2, 2021
17772-131-07 17772-131 Supernus Pharmaceuticals, Inc 7 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-131-07) April 2, 2021
17772-131-30 17772-131 Supernus Pharmaceuticals, Inc 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-131-30) April 2, 2021
17772-131-60 17772-131 Supernus Pharmaceuticals, Inc 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-131-60) April 2, 2021
17772-131-90 17772-131 Supernus Pharmaceuticals, Inc 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-131-90) April 2, 2021
17772-132-01 17772-132 Supernus Pharmaceuticals, Inc 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-132-01) April 2, 2021
17772-132-07 17772-132 Supernus Pharmaceuticals, Inc 7 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-132-07) April 2, 2021
17772-132-30 17772-132 Supernus Pharmaceuticals, Inc 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-132-30) April 2, 2021
17772-132-60 17772-132 Supernus Pharmaceuticals, Inc 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-132-60) April 2, 2021
17772-132-90 17772-132 Supernus Pharmaceuticals, Inc 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-132-90) April 2, 2021
17772-133-01 17772-133 Supernus Pharmaceuticals, Inc 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-133-01) April 2, 2021
17772-133-07 17772-133 Supernus Pharmaceuticals, Inc 7 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-133-07) April 2, 2021
17772-133-30 17772-133 Supernus Pharmaceuticals, Inc 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-133-30) April 2, 2021
17772-133-60 17772-133 Supernus Pharmaceuticals, Inc 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-133-60) April 2, 2021
17772-133-90 17772-133 Supernus Pharmaceuticals, Inc 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-133-90) April 2, 2021
17772-131 17772-131 Supernus Pharmaceuticals, Inc — April 2, 2021
17772-132 17772-132 Supernus Pharmaceuticals, Inc — April 2, 2021
17772-133 17772-133 Supernus Pharmaceuticals, Inc — April 2, 2021

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity

Generated September 25, 2026 · 10 sections on this page.