LISINOPRIL

Product NDC: 53217-322
11-digit product format: 532170322
Labeler code: 53217
Product ID: 53217-322_d11181ee-cb79-432a-b030-840f2af4d15d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lisinopril
Dosage form: TABLET
Route: ORAL
Labeler: Aidarex Pharmaceuticals LLC
Application: ANDA076164
Marketing category: ANDA
Marketing start: 2017-06-14
Marketing end: 0000-00-00
Substance: LISINOPRIL
Active strength: 30 mg/1
Pharmacologic classes: Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2019-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

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
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3d	Product name	2	20170719
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53217-322-90	2020-01-31	C162847	48780-1	9d75b9cf-fa2b-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use Lisinopril safely and effectively. See full prescribing information for Lisinopril LISINOPRIL tablets USP, for oral use Initial U.S. Approval: 1988

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53217-322-90	LISINOPRIL	90 in 1 BOTTLE	TABLET	90		3

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53217-322	LISINOPRIL TABLET [AIDAREX PHARMACEUTICALS LLC]	3	Legacy NDC, 1 package rows	20180525_30c81fac-3b27-41f2-b793-4fb1132928b7.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
205326	lisinopril 30 MG Oral Tablet	PSN	30c81fac-3b27-41f2-b793-4fb1132928b7	3
205326	lisinopril 30 MG Oral Tablet	SCD	30c81fac-3b27-41f2-b793-4fb1132928b7	3

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53217-322-90	53217032290	90 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LISINOPRIL	Aidarex Pharmaceuticals LLC \| Aidarex Pharmaceuticals	2018-05-24	HUMAN PRESCRIPTION DRUG LABEL	3