LISINOPRIL

Product NDC: 50436-0353
Requested package NDC: 50436-0353-1
11-digit product format: 504360353
Labeler code: 50436
Product ID: 50436-0353_c4d985d0-4007-4f6a-87d4-60f8a00254c1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lisinopril
Dosage form: TABLET
Route: ORAL
Labeler: Unit Dose Services
Application: ANDA076180
Marketing category: ANDA
Marketing start: 2011-11-01
Marketing end: 0000-00-00
Substance: LISINOPRIL
Active strength: 10 mg/1
Pharmacologic classes: Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50436-0353	50436-0353-1	I	Inactivated by FDA		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	E	Excluded after deficient or non-compliant submission was not corrected	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	E	Excluded after deficient or non-compliant submission was not corrected	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	E	Excluded after deficient or non-compliant submission was not corrected	`bd6a592717d7…`	`303034d00443…`

Source provenance: Browse the complete Orange Book source catalog.

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A076180-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076180-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076180-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`74a2ff9319b5…`
2020-11-12 02:37 UTC	2020-11	A076180-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A076180-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A076180-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076180-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076180-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076180-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076180-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076180-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076180-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076180-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076180-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076180-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`ea99ee380514…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A076180-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076180-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076180-003	AB	1	`74a2ff9319b5…`
2020-11-12 02:37 UTC	2020-11	A076180-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A076180-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A076180-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076180-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076180-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076180-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076180-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076180-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076180-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076180-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076180-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076180-003	AB	1	`ea99ee380514…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
50436-0353-1	2024-01-30	These highlights do not include all the information needed to use LISINOPRIL TABLETS safely and effectively. See full prescribing information for LISINOPRIL TABLETS LISINOPRIL tablets, for oral use Initial U.S. Approval: 1988
50436-0353-3	2024-01-30	These highlights do not include all the information needed to use LISINOPRIL TABLETS safely and effectively. See full prescribing information for LISINOPRIL TABLETS LISINOPRIL tablets, for oral use Initial U.S. Approval: 1988
50436-0353-3	2021-10-22	These highlights do not include all the information needed to use LISINOPRIL TABLETS safely and effectively. See full prescribing information for LISINOPRIL TABLETS LISINOPRIL tablets, for oral use Initial U.S. Approval: 1988
50436-0353-3	2021-01-29	These highlights do not include all the information needed to use LISINOPRIL TABLETS safely and effectively. See full prescribing information for LISINOPRIL TABLETS LISINOPRIL tablets, for oral use Initial U.S. Approval: 1988

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50436-0353-1	LISINOPRIL	24 in 1 BOTTLE	TABLET	24		18
50436-0353-3	LISINOPRIL	90 in 1 BOTTLE	TABLET	90		18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50436-0353	LISINOPRIL TABLET [UNIT DOSE SERVICES]	18	Legacy NDC, 2 package rows	20230110_e65f2d8c-a4f6-40ba-a85d-8ee7806bd65f.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 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LISINOPRIL	LISINOPRIL	St. Mary's Medical Park Pharmacy	6051cc96-86e0-bd0b-e053-2a91aa0a5dcf	2026-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076180 application number: ANDA076180
LISINOPRIL	LISINOPRIL	REMEDYREPACK INC.	42f49299-7ae5-4d30-86eb-66b739c0e95d	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076180 application number: ANDA076180
LISINOPRIL	LISINOPRIL	St. Mary's Medical Park Pharmacy	6062fd98-7663-f4b5-e053-2a91aa0acbc3	2026-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076180 application number: ANDA076180
LISINOPRIL	LISINOPRIL	Preferred Pharmaceuticals Inc.	7e297133-669e-4780-a966-c777624e5427	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076180 application number: ANDA076180
LISINOPRIL	LISINOPRIL	Preferred Pharmaceuticals Inc.	affd3e43-077e-42e5-a865-c961624bfe93	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076180 application number: ANDA076180
LISINOPRIL	LISINOPRIL	Preferred Pharmaceuticals, Inc.	74415f95-74c9-4329-a6af-a0f165bf7887	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076180 application number: ANDA076180
LISINOPRIL	LISINOPRIL	Quality Care Products LLC	babb75f0-bccc-44e8-955a-6873344ccc21	2024-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076180 application number: ANDA076180
LISINOPRIL	LISINOPRIL	NuCare Pharmaceuticals, Inc.	4f1f76fe-816c-384a-e054-00144ff88e88	2024-12-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076180 application number: ANDA076180
LISINOPRIL	LISINOPRIL	NuCare Pharmaceuticals, Inc.	4aa518e1-d989-1fde-e054-00144ff88e88	2024-07-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076180 application number: ANDA076180
LISINOPRIL	LISINOPRIL	NuCare Pharmaceuticals, Inc.	4aa44af9-1aff-314c-e054-00144ff8d46c	2024-07-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076180 application number: ANDA076180
LISINOPRIL	LISINOPRIL	NuCare Pharmaceuticals,Inc.	5a1c5b04-b78c-c057-e053-2991aa0aa916	2024-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076180 application number: ANDA076180
LISINOPRIL	LISINOPRIL	NuCare Pharmaceuticals,Inc.	9148529f-6278-e507-e053-2995a90aa4cf	2024-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076180 application number: ANDA076180
LISINOPRIL	LISINOPRIL	NuCare Pharmaceuticals,Inc.	86e7a336-c416-6fab-e053-2a91aa0a274c	2024-06-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076180 application number: ANDA076180
LISINOPRIL	LISINOPRIL	Proficient Rx LP	e5fbefd1-4077-4e81-a0e3-e09fadc48593	2023-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076180 application number: ANDA076180
LISINOPRIL	LISINOPRIL	A-S Medication Solutions	b5683ac4-59dc-4772-8bc6-984c698afbeb	2023-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076180 application number: ANDA076180
LISINOPRIL	LISINOPRIL	Aphena Pharma Solutions - Tennessee, LLC	2dbec080-a266-4317-8d4b-b4046206416e	2022-02-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076180 application number: ANDA076180
LISINOPRIL	LISINOPRIL	Aphena Pharma Solutions - Tennessee, LLC	6ba2c7d6-bc9e-4d8b-8d1e-c14004750693	2021-08-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076180 application number: ANDA076180

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
314076	lisinopril 10 MG Oral Tablet	PSN	e65f2d8c-a4f6-40ba-a85d-8ee7806bd65f	18
314077	lisinopril 20 MG Oral Tablet	PSN	e65f2d8c-a4f6-40ba-a85d-8ee7806bd65f	18
311354	lisinopril 5 MG Oral Tablet	PSN	e65f2d8c-a4f6-40ba-a85d-8ee7806bd65f	18
314076	lisinopril 10 MG Oral Tablet	SCD	e65f2d8c-a4f6-40ba-a85d-8ee7806bd65f	18
314077	lisinopril 20 MG Oral Tablet	SCD	e65f2d8c-a4f6-40ba-a85d-8ee7806bd65f	18
311354	lisinopril 5 MG Oral Tablet	SCD	e65f2d8c-a4f6-40ba-a85d-8ee7806bd65f	18

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50436-0353-1	50436035301	24 TABLET in 1 BOTTLE (50436-0353-1)	24 tablet	2021-10-12	0000-00-00	No	No	Current