Application 076102

Type: ANDA
Sponsor: COREPHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LISINOPRIL	LISINOPRIL	TABLET;ORAL	2.5MG	No	No
002	LISINOPRIL	LISINOPRIL	TABLET;ORAL	5MG	No	No
003	LISINOPRIL	LISINOPRIL	TABLET;ORAL	10MG	No	No
004	LISINOPRIL	LISINOPRIL	TABLET;ORAL	20MG	No	No
005	LISINOPRIL	LISINOPRIL	TABLET;ORAL	30MG	No	No
006	LISINOPRIL	LISINOPRIL	TABLET;ORAL	40MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 252 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
2026-08-18 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…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076102-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2002-09-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076102-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2002-09-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076102-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-09-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076102-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-09-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076102-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-09-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076102-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-09-30	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 252 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076102-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076102-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076102-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076102-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076102-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076102-004	AB	1	`03ed91905a0d…`

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 · 8 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
lisinopril	LISINOPRIL	REMEDYREPACK INC.	c57e8bc8-ff50-431e-9c1a-384503584d02	2025-10-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076102 application number: ANDA076102
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