Lisinopril

Product NDC: 54458-994
11-digit product format: 544580994
Labeler code: 54458
Product ID: 54458-994_67adc531-9d85-4b5a-a5b8-0b7ae9f41768
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lisinopril
Dosage form: TABLET
Route: ORAL
Labeler: International Laboratories, LLC
Application: ANDA077321
Marketing category: ANDA
Marketing start: 2008-02-01
Marketing end: 0000-00-00
Substance: LISINOPRIL
Active strength: 40 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	54458-994		I	Inactivated by FDA		2026-10-05
excluded package	package	54458-994	54458-994-10	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 · 40 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54458-994-10	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54458-994-10	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54458-994-10	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54458-994-10	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54458-994-10	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	54458-994-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	54458-994-10	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	54458-994-10	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	54458-994-10	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	54458-994-10	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	54458-994-10	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	54458-994-10	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	54458-994-10	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	54458-994-10	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	54458-994-10	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	54458-994-10	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	54458-994-10	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	54458-994-10	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	54458-994-10	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	54458-994-10	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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	TE codes	Approval date
A077321-001	LISINOPRIL	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2005-09-09
A077321-002	LISINOPRIL	LISINOPRIL	5MG	TABLET / ORAL	AB	2005-09-09
A077321-003	LISINOPRIL	LISINOPRIL	10MG	TABLET / ORAL	AB	2005-09-09
A077321-004	LISINOPRIL	LISINOPRIL	20MG	TABLET / ORAL	AB	2005-09-09
A077321-005	LISINOPRIL	LISINOPRIL	30MG	TABLET / ORAL	AB	2005-09-09
A077321-006	LISINOPRIL	LISINOPRIL	40MG	TABLET / ORAL	AB	2005-09-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
A077321-001	AB
A077321-002	AB
A077321-003	AB
A077321-004	AB
A077321-005	AB
A077321-006	AB

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	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077321-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2005-09-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077321-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2005-09-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077321-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2005-09-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077321-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2005-09-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077321-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2005-09-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077321-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2005-09-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077321-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2005-09-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077321-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2005-09-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077321-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2005-09-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077321-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2005-09-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077321-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2005-09-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077321-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2005-09-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077321-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2005-09-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077321-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2005-09-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077321-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2005-09-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077321-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2005-09-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077321-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2005-09-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077321-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2005-09-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077321-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2005-09-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077321-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2005-09-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077321-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2005-09-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077321-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2005-09-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077321-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2005-09-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077321-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2005-09-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077321-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2005-09-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077321-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2005-09-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077321-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2005-09-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077321-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2005-09-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077321-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2005-09-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077321-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2005-09-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077321-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2005-09-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077321-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2005-09-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077321-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2005-09-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077321-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2005-09-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077321-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2005-09-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077321-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2005-09-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077321-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2005-09-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077321-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2005-09-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077321-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2005-09-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077321-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2005-09-09	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 258 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A077321-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077321-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077321-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077321-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077321-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077321-006	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077321-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077321-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077321-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077321-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077321-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077321-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077321-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077321-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077321-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077321-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077321-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077321-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077321-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077321-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077321-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077321-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077321-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077321-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077321-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077321-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077321-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077321-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077321-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077321-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077321-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077321-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077321-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077321-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077321-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077321-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077321-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077321-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077321-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077321-004	AB	1	`b8a1b40f171c…`

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
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3d	Product name	2	20170719

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
54458-994-10	2021-01-29	C162847	48780-1	ba0f9c33-1671-a910-e053-dadaa90a0b85	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
54458-994-10	Lisinopril	30 in 1 BLISTER PACK	TABLET	30		44

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54458-994-10	EA - Each	54458-994	78148c2b-0122-4cfe-8bda-e947ab7d11c4	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LISINOPRIL	ACTIVE INGREDIENT	E7199S1YWR	LISINOPRIL TABLET [INTERNATIONAL LABORATORIES, INC.]	33
LISINOPRIL ANHYDROUS	ACTIVE MOIETY	7Q3P4BS2FD	LISINOPRIL TABLET [INTERNATIONAL LABORATORIES, INC.]	33
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	L11K75P92J	LISINOPRIL TABLET [INTERNATIONAL LABORATORIES, INC.]	33
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	LISINOPRIL TABLET [INTERNATIONAL LABORATORIES, INC.]	33
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	LISINOPRIL TABLET [INTERNATIONAL LABORATORIES, INC.]	33
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LISINOPRIL TABLET [INTERNATIONAL LABORATORIES, INC.]	33
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	LISINOPRIL TABLET [INTERNATIONAL LABORATORIES, INC.]	33
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LISINOPRIL TABLET [INTERNATIONAL LABORATORIES, INC.]	33
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LISINOPRIL TABLET [INTERNATIONAL LABORATORIES, INC.]	33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54458-994	LISINOPRIL TABLET [INTERNATIONAL LABORATORIES, LLC]	44	Legacy NDC, 1 package rows	20191219_9c52ca06-463b-479f-ad14-48f3d57fea14.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 3 · 57 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lisinopril	LISINOPRIL	REMEDYREPACK INC.	aa5d68e7-c2b9-41eb-ade4-2cd57edc1533	2026-09-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	REMEDYREPACK INC.	463308ef-16cb-41d8-8d29-6aae2c5a7b0f	2026-08-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	REMEDYREPACK INC.	34bb4602-ccff-4939-91b9-26a63bfd40f7	2026-08-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	REMEDYREPACK INC.	a33d860a-1e17-45b7-aede-51ab3223bebd	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	A-S Medication Solutions	88b5a2c0-6ad2-48e7-9ffe-715d9159f389	2026-07-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	A-S Medication Solutions	34953f77-bae1-41fe-af11-3ea0b3ceaa11	2026-07-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	REMEDYREPACK INC.	3451292b-7867-4dc2-afaa-da66b4016017	2026-07-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	REMEDYREPACK INC.	d32923fe-a323-43c6-af46-bcba7274b0bf	2026-07-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	Unit Dose Solutions, Inc.	551665a0-9a92-55df-e063-6394a90a1e2e	2026-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	Unit Dose Solutions, Inc.	55189717-f5db-9c63-e063-6294a90a6bc9	2026-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	Unit Dose Solutions, Inc.	55191baa-f812-2e71-e063-6294a90a8edf	2026-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	PD-Rx Pharmaceuticals, Inc.	c621c33b-cb67-4ea6-b2bd-96c20a244ea4	2026-06-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	Coupler LLC	538429b8-4f10-e825-e063-6294a90a5905	2026-06-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	Cardinal Health 107, LLC	1d0caa63-9ea2-4a97-a23b-900a7c514bc6	2026-05-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	Coupler LLC	518a63e3-8ca1-bbd1-e063-6294a90aa524	2026-05-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	Coupler LLC	509a46cf-7a89-b6c0-e063-6394a90a7509	2026-04-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	Bryant Ranch Prepack	08b0555e-41d2-44c3-b27b-ad5d701378dc	2026-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	Bryant Ranch Prepack	59fd2167-4da4-9143-83bd-3b6aa5051511	2026-03-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	REMEDYREPACK INC.	a35079fa-b693-45e8-9715-488e33e7c1a9	2026-02-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	REMEDYREPACK INC.	f22bfb4d-dda6-4c7f-a485-cfb7710ef3de	2026-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321

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	9c52ca06-463b-479f-ad14-48f3d57fea14	44
311353	lisinopril 2.5 MG Oral Tablet	PSN	9c52ca06-463b-479f-ad14-48f3d57fea14	44
314077	lisinopril 20 MG Oral Tablet	PSN	9c52ca06-463b-479f-ad14-48f3d57fea14	44
205326	lisinopril 30 MG Oral Tablet	PSN	9c52ca06-463b-479f-ad14-48f3d57fea14	44
197884	lisinopril 40 MG Oral Tablet	PSN	9c52ca06-463b-479f-ad14-48f3d57fea14	44
311354	lisinopril 5 MG Oral Tablet	PSN	9c52ca06-463b-479f-ad14-48f3d57fea14	44
314076	lisinopril 10 MG Oral Tablet	SCD	9c52ca06-463b-479f-ad14-48f3d57fea14	44
311353	lisinopril 2.5 MG Oral Tablet	SCD	9c52ca06-463b-479f-ad14-48f3d57fea14	44
314077	lisinopril 20 MG Oral Tablet	SCD	9c52ca06-463b-479f-ad14-48f3d57fea14	44
205326	lisinopril 30 MG Oral Tablet	SCD	9c52ca06-463b-479f-ad14-48f3d57fea14	44
197884	lisinopril 40 MG Oral Tablet	SCD	9c52ca06-463b-479f-ad14-48f3d57fea14	44
311354	lisinopril 5 MG Oral Tablet	SCD	9c52ca06-463b-479f-ad14-48f3d57fea14	44

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
54458-994-10	54458099410	30 in 1 BLISTER PACK	Historical