LISINOPRIL

Product NDC: 50436-0376
11-digit product format: 504360376
Labeler code: 50436
Product ID: 50436-0376_87f12ef8-77a2-4849-b7eb-a837bfc3a6aa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lisinopril
Dosage form: TABLET
Route: ORAL
Labeler: Unit Dose Services
Application: ANDA202554
Marketing category: ANDA
Marketing start: 2016-06-02
Marketing end: 0000-00-00
Substance: LISINOPRIL
Active strength: 5 mg/1
Pharmacologic classes: Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	50436-0376		I	Inactivated by FDA		2026-10-05
excluded package	package	50436-0376	50436-0376-1	I	Inactivated by FDA		2026-10-05

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 · 38 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50436-0376-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50436-0376-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50436-0376-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50436-0376-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50436-0376-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50436-0376-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50436-0376-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50436-0376-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50436-0376-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50436-0376-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50436-0376-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50436-0376-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50436-0376-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50436-0376-1	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50436-0376-1	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	50436-0376-1	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	50436-0376-1	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	50436-0376-1	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	50436-0376-1	`8dfbde2a14a4…`	`c9ff85d89658…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A202554-001	LISINOPRIL	LISINOPRIL	2.5MG	TABLET / ORAL	2013-07-30
A202554-002	LISINOPRIL	LISINOPRIL	5MG	TABLET / ORAL	2013-07-30
A202554-003	LISINOPRIL	LISINOPRIL	10MG	TABLET / ORAL	2013-07-30
A202554-004	LISINOPRIL	LISINOPRIL	20MG	TABLET / ORAL	2013-07-30
A202554-005	LISINOPRIL	LISINOPRIL	30MG	TABLET / ORAL	2013-07-30
A202554-006	LISINOPRIL	LISINOPRIL	40MG	TABLET / ORAL	2013-07-30

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 7 · 258 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A202554-001	LISINOPRIL	2.5MG	TABLET / ORAL	2013-07-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202554-002	LISINOPRIL	5MG	TABLET / ORAL	2013-07-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202554-003	LISINOPRIL	10MG	TABLET / ORAL	2013-07-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202554-004	LISINOPRIL	20MG	TABLET / ORAL	2013-07-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202554-005	LISINOPRIL	30MG	TABLET / ORAL	2013-07-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202554-006	LISINOPRIL	40MG	TABLET / ORAL	2013-07-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202554-001	LISINOPRIL	2.5MG	TABLET / ORAL	2013-07-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202554-002	LISINOPRIL	5MG	TABLET / ORAL	2013-07-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202554-003	LISINOPRIL	10MG	TABLET / ORAL	2013-07-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202554-004	LISINOPRIL	20MG	TABLET / ORAL	2013-07-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202554-005	LISINOPRIL	30MG	TABLET / ORAL	2013-07-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202554-006	LISINOPRIL	40MG	TABLET / ORAL	2013-07-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202554-001	LISINOPRIL	2.5MG	TABLET / ORAL	2013-07-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202554-002	LISINOPRIL	5MG	TABLET / ORAL	2013-07-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202554-003	LISINOPRIL	10MG	TABLET / ORAL	2013-07-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202554-004	LISINOPRIL	20MG	TABLET / ORAL	2013-07-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202554-005	LISINOPRIL	30MG	TABLET / ORAL	2013-07-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202554-006	LISINOPRIL	40MG	TABLET / ORAL	2013-07-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202554-001	LISINOPRIL	2.5MG	TABLET / ORAL	2013-07-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202554-002	LISINOPRIL	5MG	TABLET / ORAL	2013-07-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202554-003	LISINOPRIL	10MG	TABLET / ORAL	2013-07-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202554-004	LISINOPRIL	20MG	TABLET / ORAL	2013-07-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202554-005	LISINOPRIL	30MG	TABLET / ORAL	2013-07-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202554-006	LISINOPRIL	40MG	TABLET / ORAL	2013-07-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202554-001	LISINOPRIL	2.5MG	TABLET / ORAL	2013-07-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202554-002	LISINOPRIL	5MG	TABLET / ORAL	2013-07-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202554-003	LISINOPRIL	10MG	TABLET / ORAL	2013-07-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202554-004	LISINOPRIL	20MG	TABLET / ORAL	2013-07-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202554-005	LISINOPRIL	30MG	TABLET / ORAL	2013-07-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202554-006	LISINOPRIL	40MG	TABLET / ORAL	2013-07-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202554-001	LISINOPRIL	2.5MG	TABLET / ORAL	2013-07-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202554-002	LISINOPRIL	5MG	TABLET / ORAL	2013-07-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202554-003	LISINOPRIL	10MG	TABLET / ORAL	2013-07-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202554-004	LISINOPRIL	20MG	TABLET / ORAL	2013-07-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202554-005	LISINOPRIL	30MG	TABLET / ORAL	2013-07-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202554-006	LISINOPRIL	40MG	TABLET / ORAL	2013-07-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202554-001	LISINOPRIL	2.5MG	TABLET / ORAL	2013-07-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202554-002	LISINOPRIL	5MG	TABLET / ORAL	2013-07-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202554-003	LISINOPRIL	10MG	TABLET / ORAL	2013-07-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202554-004	LISINOPRIL	20MG	TABLET / ORAL	2013-07-30	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 5 · 162 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-12-28 21:50 UTC	2021-12	A202554-005	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202554-006	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202554-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202554-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202554-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202554-004	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202554-005	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202554-006	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202554-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A202554-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A202554-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A202554-004	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A202554-005	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A202554-006	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202554-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A202554-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A202554-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A202554-004	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A202554-005	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A202554-006	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202554-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A202554-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A202554-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A202554-004	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A202554-005	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A202554-006	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202554-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A202554-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A202554-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A202554-004	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A202554-005	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A202554-006	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202554-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A202554-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A202554-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A202554-004	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A202554-005	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A202554-006	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202554-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A202554-002	AB	1	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50436-0376-1	2021-01-29	C162847	48780-1	ba0f9c33-226a-a910-e053-dadaa90a0b85	These highlights do not include all the information needed to use LISINOPRIL safely and effectively. See full prescribing information for LISINOPRIL 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
50436-0376-1	LISINOPRIL	30 in 1 BOTTLE	TABLET	30		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50436-0376	LISINOPRIL TABLET [UNIT DOSE SERVICES]	3	Legacy NDC, 1 package rows	20170228_052468a2-56df-4641-a343-3733f3ebe66e.zip

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
311354	lisinopril 5 MG Oral Tablet	PSN	052468a2-56df-4641-a343-3733f3ebe66e	3
311354	lisinopril 5 MG Oral Tablet	SCD	052468a2-56df-4641-a343-3733f3ebe66e	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
50436-0376-1	50436037601	30 in 1 BOTTLE	Historical