Qbrexza

Orange BookUNIISPLATC D11AA01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerJourney Medical Corporation

CountryUS (United States)

ATC codeD11AA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6948941105
5 POUCH in 1 CARTON (69489-411-05) / 2.8 g in 1 POUCH (69489-411-51)
ndc11
6948941130
30 POUCH in 1 CARTON (69489-411-30) / 2.8 g in 1 POUCH (69489-411-01)

Annotations

UNII (FDA Substance ID)

1PVF6JLU7B

GLYCOPYRRONIUM TOSYLATE

RxCUI 2052857

Orange Book

N210361

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "1PVF6JLU7B",
    "rxcui": "2052857",
    "inchikey": "UOWOLENSDISMPG-FFUVTKDNSA-M;UOWOLENSDISMPG-WGMYLSDTSA-M",
    "display_name": "GLYCOPYRRONIUM TOSYLATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "5b372650-e56e-47a5-93e2-c0c292017059": {
      "match": "brand_token",
      "title": "QBREXZA (GLYCOPYRRONIUM) CLOTH [JOURNEY MEDICAL CORPORATION]",
      "spl_version": "5",
      "published_date": "2026-05-22"
    }
  },
  "productid": "69489-411_52537ea0-9410-1691-e063-6394a90a9468",
  "productndc": "69489-411",
  "dosage_form": "CLOTH",
  "orange_book": {
    "appl_no": "210361",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 2.4% BASE",
        "product_no": "001",
        "approval_date": "Jun 28, 2018"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GLYCOPYRRONIUM TOSYLATE",
  "proprietary_name": "Qbrexza",
  "active_ingred_unit": "g/100g",
  "application_number": "NDA210361",
  "marketing_category": "NDA",
  "nonproprietary_name": "glycopyrronium",
  "start_marketing_date": "20180628",
  "active_numerator_strength": "2.4"
}

Related drugs

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