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United States · US · US:52652-3001_461e97d5-c8b3-75a7-e063-6394a90a6ec6

Qbrelis

Orange BookUNIISPLATC C09AA03

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

Identification

ManufacturerAzurity Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeC09AA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5265230011
    150 mL in 1 BOTTLE (52652-3001-1)

Annotations

UNII (FDA Substance ID)
E7199S1YWR
LISINOPRIL
RxCUI 29046
Orange Book
N208401
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "E7199S1YWR",
    "rxcui": "29046",
    "inchikey": "CZRQXSDBMCMPNJ-ZUIPZQNBSA-N",
    "display_name": "LISINOPRIL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "9f6e4e57-a489-4b36-b093-b93865d3717c": {
      "match": "brand_token",
      "title": "QBRELIS (LISINOPRIL) SOLUTION [AZURITY PHARMACEUTICALS, INC.]",
      "spl_version": "10",
      "published_date": "2025-12-18"
    }
  },
  "productid": "52652-3001_461e97d5-c8b3-75a7-e063-6394a90a6ec6",
  "productndc": "52652-3001",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "208401",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "1MG/ML",
        "product_no": "001",
        "approval_date": "Jul 29, 2016"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LISINOPRIL",
  "proprietary_name": "Qbrelis",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA208401",
  "marketing_category": "NDA",
  "nonproprietary_name": "lisinopril",
  "start_marketing_date": "20160829",
  "active_numerator_strength": "1"
}

Related drugs

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