Lisinopril

Product NDC: 68645-552
11-digit product format: 686450552
Labeler code: 68645
Product ID: 68645-552_c9eebd5b-3622-d2f5-e053-2a95a90a87db
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lisinopril
Dosage form: TABLET
Route: ORAL
Labeler: Legacy Pharmaceutical Packaging, LLC
Application: ANDA077321
Marketing category: ANDA
Marketing start: 2006-01-13
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: 2022-12-31
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	68645-552		D	Discontinued by firm		2026-10-05
excluded package	package	68645-552	68645-552-54	D	Discontinued by firm		2026-10-05

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68645-552-54	EA - Each	68645-552	24084b88-e163-4838-9295-14089cd609f5	1	2017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68645-552	LISINOPRIL TABLET [LEGACY PHARMACEUTICAL PACKAGING, LLC]	20	Legacy NDC	20241013_a9a9b82f-d02d-4a70-9af0-9100dddc16c9.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 3 of 3 · 57 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lisinopril	LISINOPRIL	NCS HealthCare of KY, LLC dba Vangard Labs	3121a4c6-d5c2-4608-a0be-2d9f4b955d5f	2024-10-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	NCS HealthCare of KY, LLC dba Vangard Labs	43fa9a16-c112-419f-8d7b-177f580462f2	2024-09-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	American Health Packaging	50ae0dfe-d961-4bc0-9898-71f69f9a5403	2024-09-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	NuCare Pharmaceuticals,Inc.	7cd7c59d-ce52-1f5b-e053-2a91aa0a8f86	2024-06-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	A-S Medication Solutions	cce5bcc0-2e38-41d8-a41e-4f4ea83e6248	2024-01-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	A-S Medication Solutions	24aab432-9c51-4aee-b9b6-f38816d613bb	2024-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	Proficient Rx LP	726a6f23-737a-4866-b4ba-b3c18cd2e1ac	2024-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	Aphena Pharma Solutions - Tennessee, LLC	021831ab-dfeb-40fc-aede-4aa1fbb8d918	2023-08-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	A-S Medication Solutions	24f678c8-bb66-481e-b42b-1367cbff3169	2023-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	A-S Medication Solutions	051375d4-7d38-45b3-9ca4-f2cd1f527b1b	2023-03-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	Proficient Rx LP	ad211de8-d236-48aa-bf27-4501eccfffca	2023-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	Proficient Rx LP	b2d493bf-f4d8-4941-8c54-2728d769f6ed	2022-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	Aphena Pharma Solutions - Tennessee, LLC	b8a2a160-0287-41dc-a717-c7fcde7e091f	2022-03-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	Aphena Pharma Solutions - Tennessee, LLC	1b9ddfd8-0acc-4fb5-a948-bb2c0cc23a91	2022-03-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	BluePoint Laboratories	34ebeea1-6812-4697-84c4-b2ae4f39e55f	2021-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	Aphena Pharma Solutions - Tennessee, LLC	971a7e3d-0091-4174-a677-a3f49fe86a0e	2021-04-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	Proficient Rx LP	d87620e1-1a43-43a2-ab37-b9111ea5c17e	2019-11-01	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68645-552-54	68645055254	30 TABLET in 1 BOTTLE (68645-552-54)	30 tablet	2006-01-13	0000-00-00	No	No	Current