FDA.reportPublic FDA data

NDC 52652-3001-01 - Qbrelis

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
52652-3001
Requested NDC
52652-3001-01
Package NDCs from labels
52652-3001-1, 52652-3001-01
Manufacturer
Azurity Pharmaceuticals, Inc.
Effective date
2025-12-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Qbrelis - Azurity Pharmaceuticals, Inc.Azurity Pharmaceuticals, Inc.2025-12-16HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52652-3001-12024-01-30C16284748780-11030e364-fc5f-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use QBRELIS ® safely and effectively. See full prescribing information for QBRELIS. QBRELIS (lisinopril) oral solution Initial U.S. Approval: 1988

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52652-3001-1Qbrelis150 mL in 1 BOTTLESOLUTION15010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52652-3001QBRELIS (LISINOPRIL) SOLUTION [AZURITY PHARMACEUTICALS, INC.]9Current NDC, Legacy NDC, 1 package rows20240724_9f6e4e57-a489-4b36-b093-b93865d3717c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52652-3001-1ML - Milliliter52652-30019d02b4c1-832d-4c98-8976-b5f7716d120212016-09-02

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 26 · 506 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LisinoprilLISINOPRILREMEDYREPACK INC.aa5d68e7-c2b9-41eb-ade4-2cd57edc15332026-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: E7199S1YWR
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSREMEDYREPACK INC.3bea11a3-eb07-46b2-9b91-f8a48a2f3b7e2026-08-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: E7199S1YWR
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
LisinoprilLISINOPRILREMEDYREPACK INC.463308ef-16cb-41d8-8d29-6aae2c5a7b0f2026-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: E7199S1YWR
LisinoprilLISINOPRILREMEDYREPACK INC.34bb4602-ccff-4939-91b9-26a63bfd40f72026-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: E7199S1YWR
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSProficient Rx LP43a4d6dd-bcca-412c-b051-ed470208ddb62026-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: E7199S1YWR
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
IDkit HP ONECITRIC ACID ANHYDROUS AND 13C UREAMeridian Bioscience Israel Ltd8baab7a7-5d20-46ad-9c4a-762992ef6b512026-07-28Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEAurobindo Pharma Limitedd7214539-6c3d-466a-a474-6fde096fa1822026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: E7199S1YWR
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
LisinoprilLISINOPRILAurobindo Pharma Limited0e6364a4-6d66-4151-8197-d45e2a7628952026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: E7199S1YWR
LISINOPRILLISINOPRILSt. Mary's Medical Park Pharmacy6051cc96-86e0-bd0b-e053-2a91aa0a5dcf2026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: E7199S1YWR
LisinoprilLISINOPRILREMEDYREPACK INC.a33d860a-1e17-45b7-aede-51ab3223bebd2026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: E7199S1YWR
LISINOPRILLISINOPRILREMEDYREPACK INC.42f49299-7ae5-4d30-86eb-66b739c0e95d2026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: E7199S1YWR
LISINOPRILLISINOPRILREMEDYREPACK INC.12d6fe7e-b5a2-4d49-9a06-a6150234d0612026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: E7199S1YWR
LISINOPRILLISINOPRILCoupler LLC560513ef-4d2c-8ca0-e063-6394a90a674a2026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: E7199S1YWR

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.