LISINOPRIL

Product NDC: 43353-297
11-digit product format: 433530297
Labeler code: 43353
Product ID: 43353-297_50eb65e3-af02-4008-b713-b11f6f61e254
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lisinopril
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA076164
Marketing category: ANDA
Marketing start: 2011-11-01
Marketing end: 0000-00-00
Substance: LISINOPRIL
Active strength: 20 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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	43353-297		D	Discontinued by firm	2026-10-12
excluded package	package	43353-297	43353-297-30	D	Discontinued by firm	2026-10-12
excluded package	package	43353-297	43353-297-45	D	Discontinued by firm	2026-10-12
excluded package	package	43353-297	43353-297-60	D	Discontinued by firm	2026-10-12
excluded package	package	43353-297	43353-297-80	D	Discontinued by firm	2026-10-12

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
A076164-001	LISINOPRIL	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01
A076164-002	LISINOPRIL	LISINOPRIL	30MG	TABLET / ORAL	AB	2002-07-01
A076164-003	LISINOPRIL	LISINOPRIL	40MG	TABLET / ORAL	AB	2002-07-01
A076164-004	LISINOPRIL	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01
A076164-005	LISINOPRIL	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01
A076164-006	LISINOPRIL	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076164-001	AB
A076164-002	AB
A076164-003	AB
A076164-004	AB
A076164-005	AB
A076164-006	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 · 243 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	A076164-001	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076164-002	LISINOPRIL	30MG	TABLET / ORAL	AB	2002-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076164-003	LISINOPRIL	40MG	TABLET / ORAL	AB	2002-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076164-004	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076164-005	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076164-006	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076164-001	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076164-002	LISINOPRIL	30MG	TABLET / ORAL	AB	2002-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076164-003	LISINOPRIL	40MG	TABLET / ORAL	AB	2002-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076164-004	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076164-005	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076164-006	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076164-001	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076164-002	LISINOPRIL	30MG	TABLET / ORAL	AB	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076164-003	LISINOPRIL	40MG	TABLET / ORAL	AB	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076164-004	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076164-005	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076164-006	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076164-001	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076164-002	LISINOPRIL	30MG	TABLET / ORAL	AB	2002-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076164-003	LISINOPRIL	40MG	TABLET / ORAL	AB	2002-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076164-004	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076164-005	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076164-006	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076164-001	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076164-002	LISINOPRIL	30MG	TABLET / ORAL	AB	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076164-003	LISINOPRIL	40MG	TABLET / ORAL	AB	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076164-004	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076164-005	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076164-006	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076164-001	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076164-002	LISINOPRIL	30MG	TABLET / ORAL	AB	2002-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076164-003	LISINOPRIL	40MG	TABLET / ORAL	AB	2002-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076164-004	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076164-005	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076164-006	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076164-001	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076164-002	LISINOPRIL	30MG	TABLET / ORAL	AB	2002-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076164-003	LISINOPRIL	40MG	TABLET / ORAL	AB	2002-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076164-004	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 243 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	A076164-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076164-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076164-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076164-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076164-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076164-006	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076164-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076164-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076164-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076164-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076164-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076164-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076164-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076164-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076164-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076164-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076164-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076164-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076164-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076164-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076164-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076164-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076164-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076164-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076164-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076164-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076164-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076164-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076164-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076164-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076164-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076164-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076164-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076164-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076164-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076164-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076164-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076164-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076164-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076164-004	AB	1	`b8a1b40f171c…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43353-297-30	EA - Each	43353-297	d74a1036-c4b1-47e5-bdf4-52e0a1856241	1	2019-01-24
43353-297-45	EA - Each	43353-297	e73d4355-4fda-4eac-b918-f7b96d8c0ec4	1	2017-11-06
43353-297-60	EA - Each	43353-297	66df2535-7b4a-4974-9a51-e7eed15b22a2	1	2017-11-06
43353-297-80	EA - Each	43353-297	b1bf6f8b-c953-4618-8d9a-445bbe368226	1	2017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-297	LISINOPRIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2	Legacy NDC	20171021_ccb917f4-beec-4471-9683-2c5388e96ead.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 2 of 3 · 50 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LISINOPRIL	LISINOPRIL	Northwind Health Company, LLC	db98aaba-5925-f81b-e053-2a95a90a4879	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076164 application number: ANDA076164
LISINOPRIL	LISINOPRIL	QPharma, Inc.	cfd31165-5902-4c94-8fff-2940faa983c1	2025-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076164 application number: ANDA076164
LISINOPRIL	LISINOPRIL	QPharma, Inc.	c3bcfcae-a9ab-4a57-876d-8749ab6c2cff	2025-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076164 application number: ANDA076164
LISINOPRIL	LISINOPRIL	QPharma, Inc.	bd436b8b-98a6-584c-e053-2995a90ac15d	2025-12-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076164 application number: ANDA076164
LISINOPRIL	LISINOPRIL	PD-Rx Pharmaceuticals, Inc.	705582ed-da8c-418f-8bb2-fc0b74ed0a88	2025-10-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076164 application number: ANDA076164
LISINOPRIL	LISINOPRIL	Bryant Ranch Prepack	a0b068b4-1e55-446b-912b-3534e9e6fb75	2025-09-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076164 application number: ANDA076164
LISINOPRIL	LISINOPRIL	A-S Medication Solutions	a881df2d-e3b7-413f-b4bb-2c3d917b0811	2025-08-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076164 application number: ANDA076164
LISINOPRIL	LISINOPRIL	A-S Medication Solutions	d81deeaf-7e5e-44c5-9348-5923c4e3ccd6	2025-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076164 application number: ANDA076164
LISINOPRIL	LISINOPRIL	Asclemed USA, Inc.	db5bfa2f-07b8-4f79-8a40-691da006e2ed	2025-05-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076164 application number: ANDA076164
LISINOPRIL	LISINOPRIL	PD-Rx Pharmaceuticals, Inc.	bf59ff89-a9fa-4fe3-b167-a5d0cba9e438	2025-04-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076164 application number: ANDA076164
LISINOPRIL	LISINOPRIL	PD-Rx Pharmaceuticals, Inc.	03a497fe-fb09-4b2c-8ee0-2019600192b8	2025-04-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076164 application number: ANDA076164
LISINOPRIL	LISINOPRIL	PD-Rx Pharmaceuticals, Inc.	dd015c18-1ea6-44e3-9186-8d2f8444d874	2025-04-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076164 application number: ANDA076164
LISINOPRIL	LISINOPRIL	PD-Rx Pharmaceuticals, Inc.	e4c11545-00da-4675-856a-7e600a2f4bd9	2025-04-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076164 application number: ANDA076164
LISINOPRIL	LISINOPRIL	Quality Care Products LLC	29e9ac54-f9da-495c-9102-2aac2cc7d88a	2024-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076164 application number: ANDA076164
LISINOPRIL	LISINOPRIL	A-S Medication Solutions	8f63c3e0-0b3f-4a04-a592-2ce10dfda202	2024-10-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076164 application number: ANDA076164
LISINOPRIL	LISINOPRIL	Bryant Ranch Prepack	06ca101e-4498-4c4e-b455-01915e7ecca0	2024-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076164 application number: ANDA076164
LISINOPRIL	LISINOPRIL	Bryant Ranch Prepack	24f532f2-c41e-4d1d-989e-7a56b60fbdd4	2024-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076164 application number: ANDA076164
LISINOPRIL	LISINOPRIL	Bryant Ranch Prepack	0bf433cb-bf7d-4b41-9518-400646f9aa2a	2024-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076164 application number: ANDA076164
LISINOPRIL	LISINOPRIL	Bryant Ranch Prepack	bebf037f-10f8-4e1f-a512-614f81deb891	2024-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076164 application number: ANDA076164
LISINOPRIL	LISINOPRIL	Bryant Ranch Prepack	37aa2542-de44-401b-a6ff-96d2e07914c7	2024-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076164 application number: ANDA076164

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
43353-297-30	43353029730	30 TABLET in 1 BOTTLE (43353-297-30)	30 tablet	2017-08-25	0000-00-00	No	No	Current
43353-297-45	43353029745	45 TABLET in 1 BOTTLE (43353-297-45)	45 tablet	2017-04-01	0000-00-00	No	No	Current
43353-297-60	43353029760	90 TABLET in 1 BOTTLE (43353-297-60)	90 tablet	2017-04-01	0000-00-00	No	No	Current
43353-297-80	43353029780	180 TABLET in 1 BOTTLE (43353-297-80)	180 tablet	2017-04-01	0000-00-00	No	No	Current