FDA.reportPublic FDA data

QELBREE

Product NDC
17772-131
11-digit product format
177720131
Labeler code
17772
Product ID
17772-131_453c9f61-1902-44ab-e063-6394a90ab639
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
viloxazine hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Supernus Pharmaceuticals, Inc
Application
NDA211964
Marketing category
NDA
Marketing start
2021-04-02
Substance
VILOXAZINE HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
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]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
QELBREE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VILOXAZINE HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOQW30I1332
Rxcui2536548, 2536554, 2536750, 2536752, 2536756, 2536758

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
261a6cfe-eb5e-41f0-a9c1-4bf839598163Product name120210928
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17772-131-01QELBREE100 in 1 BOTTLECAPSULE, EXTENDED RELEASE10014
17772-131-07QELBREE7 in 1 BOTTLECAPSULE, EXTENDED RELEASE714
17772-131-30QELBREE30 in 1 BOTTLECAPSULE, EXTENDED RELEASE3014
17772-131-60QELBREE60 in 1 BOTTLECAPSULE, EXTENDED RELEASE6014
17772-131-90QELBREE90 in 1 BOTTLECAPSULE, EXTENDED RELEASE9014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17772-131-07EA - Each17772-131672429b6-3406-474a-9c3f-f195e82d3d4812024-05-16
17772-131-30EA - Each17772-131abedc5b5-42b1-40a6-96a6-3f863d41168412021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17772-131QELBREE (VILOXAZINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [SUPERNUS PHARMACEUTICALS, INC]10Current NDC, Legacy NDC, 5 package rows20250202_aedf408d-0f84-418d-9416-7c39ddb0d29a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
253675024HR viloxazine 150 MG Extended Release Oral CapsulePSNaedf408d-0f84-418d-9416-7c39ddb0d29a14
253675624HR viloxazine 200 MG Extended Release Oral CapsulePSNaedf408d-0f84-418d-9416-7c39ddb0d29a14
2536554Qelbree 100 MG 24HR Extended Release Oral CapsulePSNaedf408d-0f84-418d-9416-7c39ddb0d29a14
2536752Qelbree 150 MG 24HR Extended Release Oral CapsulePSNaedf408d-0f84-418d-9416-7c39ddb0d29a14
2536758Qelbree 200 MG 24HR Extended Release Oral CapsulePSNaedf408d-0f84-418d-9416-7c39ddb0d29a14
2536548viloxazine 100 MG 24HR Extended Release Oral CapsulePSNaedf408d-0f84-418d-9416-7c39ddb0d29a14
253655424 HR viloxazine 100 MG Extended Release Oral Capsule [Qelbree]SBDaedf408d-0f84-418d-9416-7c39ddb0d29a14
253675224 HR viloxazine 150 MG Extended Release Oral Capsule [Qelbree]SBDaedf408d-0f84-418d-9416-7c39ddb0d29a14
253675824 HR viloxazine 200 MG Extended Release Oral Capsule [Qelbree]SBDaedf408d-0f84-418d-9416-7c39ddb0d29a14
253654824 HR viloxazine 100 MG Extended Release Oral CapsuleSCDaedf408d-0f84-418d-9416-7c39ddb0d29a14
253675024 HR viloxazine 150 MG Extended Release Oral CapsuleSCDaedf408d-0f84-418d-9416-7c39ddb0d29a14
253675624 HR viloxazine 200 MG Extended Release Oral CapsuleSCDaedf408d-0f84-418d-9416-7c39ddb0d29a14
253655424 HR Qelbree 100 MG Extended Release Oral CapsuleSYaedf408d-0f84-418d-9416-7c39ddb0d29a14
253675224 HR Qelbree 150 MG Extended Release Oral CapsuleSYaedf408d-0f84-418d-9416-7c39ddb0d29a14
253675824 HR Qelbree 200 MG Extended Release Oral CapsuleSYaedf408d-0f84-418d-9416-7c39ddb0d29a14
2536554Qelbree 100 MG 24 HR Extended Release Oral CapsuleSYaedf408d-0f84-418d-9416-7c39ddb0d29a14
2536752Qelbree 150 MG 24 HR Extended Release Oral CapsuleSYaedf408d-0f84-418d-9416-7c39ddb0d29a14
2536758Qelbree 200 MG 24 HR Extended Release Oral CapsuleSYaedf408d-0f84-418d-9416-7c39ddb0d29a14
2536548viloxazine 100 MG (as viloxazine HCl 115 MG) 24 HR Extended Release Oral CapsuleSYaedf408d-0f84-418d-9416-7c39ddb0d29a14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
17772-131-0117772013101100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-131-01) 2021-04-020000-00-00NoNoCurrent
17772-131-07177720131077 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-131-07) 2021-04-020000-00-00YesNoCurrent
17772-131-301777201313030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-131-30) 2021-04-020000-00-00NoNoCurrent
17772-131-601777201316060 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-131-60) 2021-04-020000-00-00NoNoCurrent
17772-131-901777201319090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-131-90) 2021-04-020000-00-00NoNoCurrent