LISINOPRIL

Product NDC: 53217-202
11-digit product format: 532170202
Labeler code: 53217
Product ID: 53217-202_78f2d3bb-e467-43a1-b038-e8889449a1ed
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lisinopril
Dosage form: TABLET
Route: ORAL
Labeler: Aidarex Pharmaceuticals LLC
Application: ANDA076180
Marketing category: ANDA
Marketing start: 2011-11-01
Marketing end: 0000-00-00
Substance: LISINOPRIL
Active strength: 3 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
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3d	Product name	2	20170719

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53217-202-10	2020-01-31	C162847	48780-1	9d75b9d0-28de-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
53217-202-30	2020-01-31	C162847	48780-1	9d75b9d0-28de-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
53217-202-90	2020-01-31	C162847	48780-1	9d75b9d0-28de-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	SPL version
53217-202-10	LISINOPRIL	100 in 1 BOTTLE	TABLET	100	1
53217-202-30	LISINOPRIL	30 in 1 BOTTLE	TABLET	30	1
53217-202-90	LISINOPRIL	90 in 1 BOTTLE	TABLET	90	1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53217-202	LISINOPRIL TABLET [AIDAREX PHARMACEUTICALS LLC]	1	Legacy NDC, 3 package rows	20170228_530f4ab6-a03b-4775-943a-62cb71b7a645.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
311353	lisinopril 2.5 MG Oral Tablet	PSN	530f4ab6-a03b-4775-943a-62cb71b7a645	1
311353	lisinopril 2.5 MG Oral Tablet	SCD	530f4ab6-a03b-4775-943a-62cb71b7a645	1

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53217-202-10	53217020210	100 in 1 BOTTLE	Historical
53217-202-30	53217020230	30 in 1 BOTTLE	Historical
53217-202-90	53217020290	90 in 1 BOTTLE	Historical