qelbree

Generic: viloxazine hydrochloride

Labeler: supernus pharmaceuticals, inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name qelbree
Generic Name viloxazine hydrochloride
Labeler supernus pharmaceuticals, inc
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

viloxazine hydrochloride 200 mg/1

Manufacturer
Supernus Pharmaceuticals, Inc

Identifiers & Regulatory

Product NDC 17772-133
Product ID 17772-133_453c9f61-1902-44ab-e063-6394a90ab639
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA211964
Listing Expiration 2026-12-31
Marketing Start 2021-04-02

Pharmacologic Class

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]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 17772133
Hyphenated Format 17772-133

Supplemental Identifiers

RxCUI
2536548 2536554 2536750 2536752 2536756 2536758
UPC
0359310210129
UNII
OQW30I1332

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name qelbree (source: ndc)
Generic Name viloxazine hydrochloride (source: ndc)
Application Number NDA211964 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-133-01)
  • 7 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-133-07)
  • 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-133-30)
  • 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-133-60)
  • 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-133-90)
source: ndc

Packages (5)

17772-133-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-133-01) 17772-133-07 7 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-133-07) 17772-133-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-133-30) 17772-133-60 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-133-60) 17772-133-90 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-133-90)

Ingredients (1)

viloxazine hydrochloride (200 mg/1)

Linked Drug Pages (1)

QELBREE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "453c9f61-1902-44ab-e063-6394a90ab639", "openfda": {"upc": ["0359310210129"], "unii": ["OQW30I1332"], "rxcui": ["2536548", "2536554", "2536750", "2536752", "2536756", "2536758"], "spl_set_id": ["aedf408d-0f84-418d-9416-7c39ddb0d29a"], "manufacturer_name": ["Supernus Pharmaceuticals, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-133-01)", "package_ndc": "17772-133-01", "marketing_start_date": "20210402"}, {"sample": true, "description": "7 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-133-07)", "package_ndc": "17772-133-07", "marketing_start_date": "20210402"}, {"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-133-30)", "package_ndc": "17772-133-30", "marketing_start_date": "20210402"}, {"sample": false, "description": "60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-133-60)", "package_ndc": "17772-133-60", "marketing_start_date": "20210402"}, {"sample": false, "description": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-133-90)", "package_ndc": "17772-133-90", "marketing_start_date": "20210402"}], "brand_name": "QELBREE", "product_id": "17772-133_453c9f61-1902-44ab-e063-6394a90ab639", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_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]"], "product_ndc": "17772-133", "generic_name": "viloxazine hydrochloride", "labeler_name": "Supernus Pharmaceuticals, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "QELBREE", "active_ingredients": [{"name": "VILOXAZINE HYDROCHLORIDE", "strength": "200 mg/1"}], "application_number": "NDA211964", "marketing_category": "NDA", "marketing_start_date": "20210402", "listing_expiration_date": "20261231"}