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United States · US · US:17772-132_453c9f61-1902-44ab-e063-6394a90ab639

QELBREE

Orange BookUNIISPLATC N06AX09

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerSupernus Pharmaceuticals, Inc
CountryUS (United States)
ATC codeN06AX09
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 5

  • ndc11
    1777213201
    100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-132-01)
  • ndc11
    1777213207
    7 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-132-07)
  • ndc11
    1777213230
    30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-132-30)
  • ndc11
    1777213260
    60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-132-60)
  • ndc11
    1777213290
    90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-132-90)

Annotations

UNII (FDA Substance ID)
OQW30I1332
VILOXAZINE HYDROCHLORIDE
RxCUI 142143
Orange Book
N211964
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "OQW30I1332",
    "rxcui": "142143",
    "inchikey": "HJOCKFVCMLCPTP-UHFFFAOYSA-N",
    "display_name": "VILOXAZINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "aedf408d-0f84-418d-9416-7c39ddb0d29a": {
      "match": "brand_token",
      "title": "QELBREE (VILOXAZINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [SUPERNUS PHARMACEUTICALS, INC]",
      "spl_version": "14",
      "published_date": "2025-12-10"
    }
  },
  "productid": "17772-132_453c9f61-1902-44ab-e063-6394a90ab639",
  "productndc": "17772-132",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "211964",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 100MG BASE",
        "product_no": "001",
        "approval_date": "Apr 2, 2021"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 150MG BASE",
        "product_no": "002",
        "approval_date": "Apr 2, 2021"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 200MG BASE",
        "product_no": "003",
        "approval_date": "Apr 2, 2021"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "VILOXAZINE HYDROCHLORIDE",
  "proprietary_name": "QELBREE",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA211964",
  "marketing_category": "NDA",
  "nonproprietary_name": "viloxazine hydrochloride",
  "start_marketing_date": "20210402",
  "active_numerator_strength": "150"
}

Related drugs

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