Home NDC 52652-3001 Qbrelis
Product NDC 52652-3001
11-digit product format 526523001
Labeler code 52652
Product ID 52652-3001_461e97d5-c8b3-75a7-e063-6394a90a6ec6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name lisinopril
Dosage form SOLUTION
Route ORAL
Labeler Azurity Pharmaceuticals, Inc.
Application NDA208401
Marketing category NDA
Marketing start 2016-08-29
Substance LISINOPRIL
Active strength 1 mg/mL
Pharmacologic classes Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N208401-001 QBRELIS LISINOPRIL 1MG/ML SOLUTION / ORAL RLD, RS 2016-07-29
Orange Book patents# Current patent rows page 1 of 1 · 32 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N208401-001 QBRELIS 1MG/ML SOLUTION / ORAL RLD, RS 2016-07-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208401-001 QBRELIS 1MG/ML SOLUTION / ORAL RLD, RS 2016-07-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208401-001 QBRELIS 1MG/ML SOLUTION / ORAL RLD, RS 2016-07-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208401-001 QBRELIS 1MG/ML SOLUTION / ORAL RLD, RS 2016-07-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208401-001 QBRELIS 1MG/ML SOLUTION / ORAL RLD, RS 2016-07-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208401-001 QBRELIS 1MG/ML SOLUTION / ORAL RLD, RS 2016-07-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208401-001 QBRELIS 1MG/ML SOLUTION / ORAL RLD, RS 2016-07-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208401-001 QBRELIS 1MG/ML SOLUTION / ORAL RLD, RS 2016-07-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208401-001 QBRELIS 1MG/ML SOLUTION / ORAL RLD, RS 2016-07-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208401-001 QBRELIS 1MG/ML SOLUTION / ORAL RLD, RS 2016-07-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208401-001 QBRELIS 1MG/ML SOLUTION / ORAL RLD, RS 2016-07-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208401-001 QBRELIS 1MG/ML SOLUTION / ORAL RLD, RS 2016-07-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208401-001 QBRELIS 1MG/ML SOLUTION / ORAL RLD, RS 2016-07-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208401-001 QBRELIS 1MG/ML SOLUTION / ORAL RLD, RS 2016-07-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208401-001 QBRELIS 1MG/ML SOLUTION / ORAL RLD, RS 2016-07-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208401-001 QBRELIS 1MG/ML SOLUTION / ORAL RLD, RS 2016-07-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208401-001 QBRELIS 1MG/ML SOLUTION / ORAL RLD, RS 2016-07-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208401-001 QBRELIS 1MG/ML SOLUTION / ORAL RLD, RS 2016-07-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208401-001 QBRELIS 1MG/ML SOLUTION / ORAL RLD, RS 2016-07-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208401-001 QBRELIS 1MG/ML SOLUTION / ORAL RLD, RS 2016-07-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208401-001 QBRELIS 1MG/ML SOLUTION / ORAL RLD, RS 2016-07-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208401-001 QBRELIS 1MG/ML SOLUTION / ORAL RLD, RS 2016-07-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208401-001 QBRELIS 1MG/ML SOLUTION / ORAL RLD, RS 2016-07-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208401-001 QBRELIS 1MG/ML SOLUTION / ORAL RLD, RS 2016-07-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208401-001 QBRELIS 1MG/ML SOLUTION / ORAL RLD, RS 2016-07-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N208401-001 QBRELIS 1MG/ML SOLUTION / ORAL RLD, RS 2016-07-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208401-001 QBRELIS 1MG/ML SOLUTION / ORAL RLD, RS 2016-07-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N208401-001 QBRELIS 1MG/ML SOLUTION / ORAL RLD, RS 2016-07-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N208401-001 QBRELIS 1MG/ML SOLUTION / ORAL RLD, RS 2016-07-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N208401-001 QBRELIS 1MG/ML SOLUTION / ORAL RLD, RS 2016-07-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N208401-001 QBRELIS 1MG/ML SOLUTION / ORAL RLD, RS 2016-07-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N208401-001 QBRELIS 1MG/ML SOLUTION / ORAL RLD, RS 2016-07-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N208401-001 QBRELIS 1MG/ML SOLUTION / ORAL RLD, RS 2016-07-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N208401-001 QBRELIS 1MG/ML SOLUTION / ORAL RLD, RS 2016-07-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N208401-001 QBRELIS 1MG/ML SOLUTION / ORAL RLD, RS 2016-07-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N208401-001 QBRELIS 1MG/ML SOLUTION / ORAL RLD, RS 2016-07-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N208401-001 QBRELIS 1MG/ML SOLUTION / ORAL RLD, RS 2016-07-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N208401-001 QBRELIS 1MG/ML SOLUTION / ORAL RLD, RS 2016-07-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N208401-001 QBRELIS 1MG/ML SOLUTION / ORAL RLD, RS 2016-07-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N208401-001 QBRELIS 1MG/ML SOLUTION / ORAL RLD, RS 2016-07-29 e64feba35796…
Observed Orange Book patent history# Patent history page 1 of 28 · 1,112 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Qbrelis
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LISINOPRIL 1 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination E7199S1YWR Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1806884 Internal RxNorm lookup 1806890 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 52652-3001-1 Qbrelis 150 mL in 1 BOTTLE SOLUTION 150 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52652-3001 QBRELIS (LISINOPRIL) SOLUTION [AZURITY PHARMACEUTICALS, INC.] 9 Current NDC, Legacy NDC, 1 package rows 20240724_9f6e4e57-a489-4b36-b093-b93865d3717c.zip
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 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Qbrelis LISINOPRIL Azurity Pharmaceuticals, Inc. 9f6e4e57-a489-4b36-b093-b93865d3717c 2025-12-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 208401 application number: NDA208401 ndc (product): 52652-3001
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 52652-3001-1 52652300101 150 mL in 1 BOTTLE (52652-3001-1) 150 ml 2016-08-29 0000-00-00 No No Current