Lisinopril

Product NDC: 43063-815
11-digit product format: 430630815
Labeler code: 43063
Product ID: 43063-815_415b9940-77ea-a174-e063-6294a90a4cfe
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lisinopril
Dosage form: TABLET
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA075743
Marketing category: ANDA
Marketing start: 2017-08-30
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: 2026-12-31
Current FDA listing: Yes

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
A075743-001	LISINOPRIL	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01
A075743-002	LISINOPRIL	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01
A075743-003	LISINOPRIL	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01
A075743-004	LISINOPRIL	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01
A075743-005	LISINOPRIL	LISINOPRIL	30MG	TABLET / ORAL	AB	2002-07-01
A075743-006	LISINOPRIL	LISINOPRIL	40MG	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
A075743-001	AB
A075743-002	AB
A075743-003	AB
A075743-004	AB
A075743-005	AB
A075743-006	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	A075743-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075743-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075743-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075743-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075743-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2002-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075743-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2002-07-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075743-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075743-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075743-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075743-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075743-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2002-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075743-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2002-07-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075743-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075743-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075743-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075743-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075743-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075743-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2002-07-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075743-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075743-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075743-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075743-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075743-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2002-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075743-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2002-07-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075743-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075743-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075743-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075743-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075743-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075743-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2002-07-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075743-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075743-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075743-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075743-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075743-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2002-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075743-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2002-07-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075743-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075743-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075743-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075743-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01	`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	A075743-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075743-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075743-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075743-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075743-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075743-006	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075743-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075743-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075743-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075743-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075743-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075743-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075743-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075743-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075743-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075743-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075743-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075743-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075743-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075743-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075743-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075743-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075743-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075743-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075743-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075743-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075743-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075743-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075743-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075743-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075743-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075743-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075743-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075743-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075743-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075743-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075743-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075743-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075743-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075743-004	AB	1	`b8a1b40f171c…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Lisinopril
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LISINOPRIL	40 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
E7199S1YWR	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197884	Internal RxNorm lookup
205326	Internal RxNorm lookup
311353	Internal RxNorm lookup
311354	Internal RxNorm lookup
314076	Internal RxNorm lookup
314077	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
b62815f3-77fc-4074-a28a-918ab5cc32db	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
43063-815-01	Lisinopril	100 in 1 BOTTLE, PLASTIC	TABLET	100	25
43063-815-30	Lisinopril	30 in 1 BOTTLE, PLASTIC	TABLET	30	25
43063-815-60	Lisinopril	60 in 1 BOTTLE, PLASTIC	TABLET	60	25
43063-815-90	Lisinopril	90 in 1 BOTTLE, PLASTIC	TABLET	90	25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43063-815-01	EA - Each	43063-815	1a79402d-e329-49be-a262-cf695ffdfdee	1	2018-02-20
43063-815-30	EA - Each	43063-815	317b3757-80e0-433b-9673-6cf3d7623d75	1	2018-02-20
43063-815-60	EA - Each	43063-815	c2c130c9-ba7a-46d4-aee1-2e0b67d5b96b	1	2018-02-20
43063-815-90	EA - Each	43063-815	cace2619-028d-4786-9e53-e427efd4eb67	1	2018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43063-815	LISINOPRIL TABLET [PD-RX PHARMACEUTICALS, INC.]	24	Current NDC, Legacy NDC, 4 package rows	20241017_b62815f3-77fc-4074-a28a-918ab5cc32db.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lisinopril	LISINOPRIL	PD-Rx Pharmaceuticals, Inc.	b62815f3-77fc-4074-a28a-918ab5cc32db	2025-10-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075743 application number: ANDA075743 ndc (product): 43063-815
Lisinopril	LISINOPRIL	Aphena Pharma Solutions - Tennessee, LLC	a79a034d-7bbb-4b05-b8fc-8ebf09f33c0c	2023-10-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075743 application number: ANDA075743
Lisinopril	LISINOPRIL	Solco healthcare U.S., LLC	f8d16c85-50e2-4d99-afae-6fb902734e42	2022-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075743 application number: ANDA075743
Lisinopril	LISINOPRIL	Aphena Pharma Solutions - Tennessee, LLC	1c0250c7-ff57-411b-852b-b8e4573f2057	2020-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075743 application number: ANDA075743

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	b62815f3-77fc-4074-a28a-918ab5cc32db	25
311353	lisinopril 2.5 MG Oral Tablet	PSN	b62815f3-77fc-4074-a28a-918ab5cc32db	25
314077	lisinopril 20 MG Oral Tablet	PSN	b62815f3-77fc-4074-a28a-918ab5cc32db	25
205326	lisinopril 30 MG Oral Tablet	PSN	b62815f3-77fc-4074-a28a-918ab5cc32db	25
197884	lisinopril 40 MG Oral Tablet	PSN	b62815f3-77fc-4074-a28a-918ab5cc32db	25
311354	lisinopril 5 MG Oral Tablet	PSN	b62815f3-77fc-4074-a28a-918ab5cc32db	25
314076	lisinopril 10 MG Oral Tablet	SCD	b62815f3-77fc-4074-a28a-918ab5cc32db	25
311353	lisinopril 2.5 MG Oral Tablet	SCD	b62815f3-77fc-4074-a28a-918ab5cc32db	25
314077	lisinopril 20 MG Oral Tablet	SCD	b62815f3-77fc-4074-a28a-918ab5cc32db	25
205326	lisinopril 30 MG Oral Tablet	SCD	b62815f3-77fc-4074-a28a-918ab5cc32db	25
197884	lisinopril 40 MG Oral Tablet	SCD	b62815f3-77fc-4074-a28a-918ab5cc32db	25
311354	lisinopril 5 MG Oral Tablet	SCD	b62815f3-77fc-4074-a28a-918ab5cc32db	25
197884	lisinopril 40 MG Oral Tablet	PSN	1c0250c7-ff57-411b-852b-b8e4573f2057	1
197884	lisinopril 40 MG Oral Tablet	SCD	1c0250c7-ff57-411b-852b-b8e4573f2057	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43063-815-01	43063081501	100 TABLET in 1 BOTTLE, PLASTIC (43063-815-01)	100 tablet	2018-01-05	0000-00-00	No	No	Current
43063-815-30	43063081530	30 TABLET in 1 BOTTLE, PLASTIC (43063-815-30)	30 tablet	2018-01-08	0000-00-00	No	No	Current
43063-815-60	43063081560	60 TABLET in 1 BOTTLE, PLASTIC (43063-815-60)	60 tablet	2018-01-11	0000-00-00	No	No	Current
43063-815-90	43063081590	90 TABLET in 1 BOTTLE, PLASTIC (43063-815-90)	90 tablet	2018-01-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lisinopril	PD-Rx Pharmaceuticals, Inc.	2025-10-17	HUMAN PRESCRIPTION DRUG LABEL	25
Lisinopril	Aphena Pharma Solutions - Tennessee, LLC	2020-04-09	HUMAN PRESCRIPTION DRUG LABEL	1