LISINOPRIL

Product NDC: 71610-727
Requested package NDC: 71610-727-45
11-digit product format: 716100727
Labeler code: 71610
Product ID: 71610-727_471f70ee-df85-0cf8-e063-6294a90ad68f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: LISINOPRIL
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA076102
Marketing category: ANDA
Marketing start: 2023-04-07
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
A076102-001	LISINOPRIL	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-09-30
A076102-002	LISINOPRIL	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-09-30
A076102-003	LISINOPRIL	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-09-30
A076102-004	LISINOPRIL	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-09-30
A076102-005	LISINOPRIL	LISINOPRIL	30MG	TABLET / ORAL	AB	2002-09-30
A076102-006	LISINOPRIL	LISINOPRIL	40MG	TABLET / ORAL	AB	2002-09-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076102-001	AB
A076102-002	AB
A076102-003	AB
A076102-004	AB
A076102-005	AB
A076102-006	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	A076102-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-09-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076102-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-09-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076102-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-09-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076102-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-09-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076102-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2002-09-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076102-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2002-09-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076102-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-09-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076102-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-09-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076102-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-09-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076102-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-09-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076102-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2002-09-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076102-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2002-09-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076102-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076102-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076102-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076102-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076102-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2002-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076102-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2002-09-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076102-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076102-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076102-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076102-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076102-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2002-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076102-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2002-09-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076102-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-09-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076102-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-09-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076102-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-09-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076102-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-09-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076102-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2002-09-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076102-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2002-09-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076102-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-09-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076102-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-09-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076102-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-09-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076102-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-09-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076102-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2002-09-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076102-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2002-09-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076102-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-09-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076102-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-09-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076102-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-09-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076102-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-09-30	`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	A076102-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076102-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076102-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076102-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076102-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076102-006	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076102-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076102-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076102-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076102-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076102-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076102-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076102-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076102-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076102-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076102-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076102-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076102-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076102-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076102-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076102-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076102-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076102-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076102-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076102-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076102-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076102-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076102-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076102-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076102-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076102-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076102-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076102-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076102-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076102-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076102-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076102-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076102-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076102-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076102-004	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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197884	Internal RxNorm lookup
314076	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
3a3d4f6c-9f68-44e4-8cf8-32742e3b5021	Available on FDA.report

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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71610-727-30	LISINOPRIL	30 in 1 BOTTLE	TABLET	30	4
71610-727-45	LISINOPRIL	45 in 1 BOTTLE	TABLET	45	4
71610-727-60	LISINOPRIL	90 in 1 BOTTLE	TABLET	90	4
71610-727-80	LISINOPRIL	180 in 1 BOTTLE	TABLET	180	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-727-30	EA - Each	71610-727	46632638-ed74-488d-b155-dae66f16568a	1	2023-12-05
71610-727-45	EA - Each	71610-727	3388eb91-3ec7-4480-83e5-9e14a8069d8f	1	2023-10-16
71610-727-60	EA - Each	71610-727	5dde6683-bd12-43ac-b8ff-e7d64cffd64c	1	2023-10-16
71610-727-80	EA - Each	71610-727	a7733914-0a58-41bc-8e5e-9843c0476d18	1	2026-03-17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-727	LISINOPRIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	3	Current NDC, 4 package rows	20230913_3a3d4f6c-9f68-44e4-8cf8-32742e3b5021.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
lisinopril	LISINOPRIL	Bryant Ranch Prepack	d8a0c806-8f5e-41c0-91c6-ad267af27a53	2026-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076102 application number: ANDA076102
LISINOPRIL	LISINOPRIL	Aphena Pharma Solutions - Tennessee, LLC	3a3d4f6c-9f68-44e4-8cf8-32742e3b5021	2025-12-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076102 application number: ANDA076102 ndc (package): 71610-727-45 ndc (product): 71610-727 ndc11 (package): 71610072745
LISINOPRIL	LISINOPRIL	Exelan Pharmaceuticals, Inc	4aad4d30-3e18-489c-80ad-ccf7532bb933	2024-05-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076102 application number: ANDA076102
LISINOPRIL	LISINOPRIL	Aphena Pharma Solutions - Tennessee, LLC	aeee8e9a-333a-416e-ab69-a0d40e146883	2024-01-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076102 application number: ANDA076102
LISINOPRIL	LISINOPRIL	Aphena Pharma Solutions - Tennessee, LLC	a32db461-4f77-46ef-b49b-250711dade17	2023-12-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076102 application number: ANDA076102
LISINOPRIL	LISINOPRIL	Aphena Pharma Solutions - Tennessee, LLC	719c4db7-ccbe-4779-baa7-a3c461f3aa52	2023-09-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076102 application number: ANDA076102
lisinopril	LISINOPRIL	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.(780779901)	c6c55efa-36bd-4613-98ca-2eb589a31e53	2023-07-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076102 application number: ANDA076102

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	3a3d4f6c-9f68-44e4-8cf8-32742e3b5021	4
197884	lisinopril 40 MG Oral Tablet	PSN	3a3d4f6c-9f68-44e4-8cf8-32742e3b5021	4
314076	lisinopril 10 MG Oral Tablet	SCD	3a3d4f6c-9f68-44e4-8cf8-32742e3b5021	4
197884	lisinopril 40 MG Oral Tablet	SCD	3a3d4f6c-9f68-44e4-8cf8-32742e3b5021	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71610-727-45	71610072745	45 TABLET in 1 BOTTLE (71610-727-45)	45 tablet	2023-08-22	No	No	Current