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

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
LISINOPRIL	1 mg/mL

Field, Values table
Field	Values
Unii	E7199S1YWR
Rxcui	1806884, 1806890

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f8f05a6d-f74b-4e9e-ab1c-374d3b4fb820	Product name	1	20230703
f65307a7-3644-0a09-cdfd-94aae8d3b53e	Product name	3	20210902
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3d	Product name	2	20170719

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52652-3001-1	2024-01-30	C162847	48780-1	1030e364-fc5f-111a-e063-dadaa90a10e2	These 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

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

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52652-3001-1	ML - Milliliter	52652-3001	9d02b4c1-832d-4c98-8976-b5f7716d1202	1	2016-09-02

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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
E7199S1YWR	LISINOPRIL	83915-83-7	LISINOPRIL

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1806884	lisinopril 1 MG in 1 mL Oral Solution	PSN	9f6e4e57-a489-4b36-b093-b93865d3717c	10
1806890	Qbrelis 1 MG in 1 mL Oral Solution	PSN	9f6e4e57-a489-4b36-b093-b93865d3717c	10
1806890	lisinopril 1 MG/ML Oral Solution [Qbrelis]	SBD	9f6e4e57-a489-4b36-b093-b93865d3717c	10
1806884	lisinopril 1 MG/ML Oral Solution	SCD	9f6e4e57-a489-4b36-b093-b93865d3717c	10
1806884	lisinopril 1 MG per 1 ML Oral Solution	SY	9f6e4e57-a489-4b36-b093-b93865d3717c	10
1806890	Qbrelis 1 MG per 1 ML Oral Solution	SY	9f6e4e57-a489-4b36-b093-b93865d3717c	10
1806890	Qbrelis 1 MG/ML Oral Solution	SY	9f6e4e57-a489-4b36-b093-b93865d3717c	10

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