Application 076071

Type: ANDA
Sponsor: MYLAN

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 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	Approval date
A076071-001	LISINOPRIL	LISINOPRIL	2.5MG	TABLET / ORAL	2002-07-01
A076071-002	LISINOPRIL	LISINOPRIL	5MG	TABLET / ORAL	2002-07-01
A076071-003	LISINOPRIL	LISINOPRIL	10MG	TABLET / ORAL	2002-07-01
A076071-004	LISINOPRIL	LISINOPRIL	20MG	TABLET / ORAL	2002-07-01
A076071-005	LISINOPRIL	LISINOPRIL	30MG	TABLET / ORAL	2002-07-01
A076071-006	LISINOPRIL	LISINOPRIL	40MG	TABLET / ORAL	2002-07-01

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A076071-001	LISINOPRIL	2.5MG	TABLET / ORAL	2002-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076071-002	LISINOPRIL	5MG	TABLET / ORAL	2002-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076071-003	LISINOPRIL	10MG	TABLET / ORAL	2002-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076071-004	LISINOPRIL	20MG	TABLET / ORAL	2002-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076071-005	LISINOPRIL	30MG	TABLET / ORAL	2002-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076071-006	LISINOPRIL	40MG	TABLET / ORAL	2002-07-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076071-001	LISINOPRIL	2.5MG	TABLET / ORAL	2002-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076071-002	LISINOPRIL	5MG	TABLET / ORAL	2002-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076071-003	LISINOPRIL	10MG	TABLET / ORAL	2002-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076071-004	LISINOPRIL	20MG	TABLET / ORAL	2002-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076071-005	LISINOPRIL	30MG	TABLET / ORAL	2002-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076071-006	LISINOPRIL	40MG	TABLET / ORAL	2002-07-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076071-001	LISINOPRIL	2.5MG	TABLET / ORAL	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076071-002	LISINOPRIL	5MG	TABLET / ORAL	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076071-003	LISINOPRIL	10MG	TABLET / ORAL	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076071-004	LISINOPRIL	20MG	TABLET / ORAL	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076071-005	LISINOPRIL	30MG	TABLET / ORAL	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076071-006	LISINOPRIL	40MG	TABLET / ORAL	2002-07-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076071-001	LISINOPRIL	2.5MG	TABLET / ORAL	2002-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076071-002	LISINOPRIL	5MG	TABLET / ORAL	2002-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076071-003	LISINOPRIL	10MG	TABLET / ORAL	2002-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076071-004	LISINOPRIL	20MG	TABLET / ORAL	2002-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076071-005	LISINOPRIL	30MG	TABLET / ORAL	2002-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076071-006	LISINOPRIL	40MG	TABLET / ORAL	2002-07-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076071-001	LISINOPRIL	2.5MG	TABLET / ORAL	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076071-002	LISINOPRIL	5MG	TABLET / ORAL	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076071-003	LISINOPRIL	10MG	TABLET / ORAL	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076071-004	LISINOPRIL	20MG	TABLET / ORAL	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076071-005	LISINOPRIL	30MG	TABLET / ORAL	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076071-006	LISINOPRIL	40MG	TABLET / ORAL	2002-07-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076071-001	LISINOPRIL	2.5MG	TABLET / ORAL	2002-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076071-002	LISINOPRIL	5MG	TABLET / ORAL	2002-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076071-003	LISINOPRIL	10MG	TABLET / ORAL	2002-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076071-004	LISINOPRIL	20MG	TABLET / ORAL	2002-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076071-005	LISINOPRIL	30MG	TABLET / ORAL	2002-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076071-006	LISINOPRIL	40MG	TABLET / ORAL	2002-07-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076071-001	LISINOPRIL	2.5MG	TABLET / ORAL	2002-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076071-002	LISINOPRIL	5MG	TABLET / ORAL	2002-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076071-003	LISINOPRIL	10MG	TABLET / ORAL	2002-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076071-004	LISINOPRIL	20MG	TABLET / ORAL	2002-07-01	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-07-19 19:46 UTC	2019-07	A076071-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076071-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076071-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076071-004	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076071-005	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076071-006	AB	1	`ea99ee380514…`

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 7 of 8 · 156 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lisinopril	LISINOPRIL	A-S Medication Solutions	cce5bcc0-2e38-41d8-a41e-4f4ea83e6248	2024-01-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lisinopril generic name: LISINOPRIL
Lisinopril	LISINOPRIL	Bryant Ranch Prepack	3783ab4c-2bed-414e-8927-62d47e3e3496	2024-01-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lisinopril generic name: LISINOPRIL
Lisinopril	LISINOPRIL	Bryant Ranch Prepack	5af2444f-438c-4ea6-96e8-3dba1af9e1a5	2024-01-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lisinopril generic name: LISINOPRIL
Lisinopril	LISINOPRIL	A-S Medication Solutions	24aab432-9c51-4aee-b9b6-f38816d613bb	2024-01-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lisinopril generic name: LISINOPRIL
LISINOPRIL	LISINOPRIL	Aphena Pharma Solutions - Tennessee, LLC	aeee8e9a-333a-416e-ab69-a0d40e146883	2024-01-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LISINOPRIL generic name: LISINOPRIL
Lisinopril	LISINOPRIL	Proficient Rx LP	726a6f23-737a-4866-b4ba-b3c18cd2e1ac	2024-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lisinopril generic name: LISINOPRIL
LISINOPRIL	LISINOPRIL	Aphena Pharma Solutions - Tennessee, LLC	a32db461-4f77-46ef-b49b-250711dade17	2023-12-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LISINOPRIL generic name: LISINOPRIL
Lisinopril	LISINOPRIL	Aphena Pharma Solutions - Tennessee, LLC	a79a034d-7bbb-4b05-b8fc-8ebf09f33c0c	2023-10-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lisinopril generic name: LISINOPRIL
LISINOPRIL	LISINOPRIL	Aphena Pharma Solutions - Tennessee, LLC	719c4db7-ccbe-4779-baa7-a3c461f3aa52	2023-09-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LISINOPRIL generic name: LISINOPRIL
Lisinopril	LISINOPRIL	Aphena Pharma Solutions - Tennessee, LLC	021831ab-dfeb-40fc-aede-4aa1fbb8d918	2023-08-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lisinopril generic name: LISINOPRIL
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	Name fallback brand name: lisinopril generic name: LISINOPRIL
LISINOPRIL	LISINOPRIL	Proficient Rx LP	3f6bc45e-448e-47f9-9bc4-991b1c503ddf	2023-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LISINOPRIL generic name: LISINOPRIL
LISINOPRIL	LISINOPRIL	Proficient Rx LP	e5fbefd1-4077-4e81-a0e3-e09fadc48593	2023-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LISINOPRIL generic name: LISINOPRIL
Lisinopril	LISINOPRIL	A-S Medication Solutions	24f678c8-bb66-481e-b42b-1367cbff3169	2023-03-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lisinopril generic name: LISINOPRIL
Lisinopril	LISINOPRIL	A-S Medication Solutions	051375d4-7d38-45b3-9ca4-f2cd1f527b1b	2023-03-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lisinopril generic name: LISINOPRIL
LISINOPRIL	LISINOPRIL	A-S Medication Solutions	b5683ac4-59dc-4772-8bc6-984c698afbeb	2023-02-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LISINOPRIL generic name: LISINOPRIL
Lisinopril	LISINOPRIL	Proficient Rx LP	ad211de8-d236-48aa-bf27-4501eccfffca	2023-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lisinopril generic name: LISINOPRIL
Lisinopril	LISINOPRIL	Solco healthcare U.S., LLC	f8d16c85-50e2-4d99-afae-6fb902734e42	2022-06-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lisinopril generic name: LISINOPRIL
Lisinopril	LISINOPRIL	Proficient Rx LP	b2d493bf-f4d8-4941-8c54-2728d769f6ed	2022-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lisinopril generic name: LISINOPRIL
LISINOPRIL	LISINOPRIL	Proficient Rx LP	3e4e69f6-b8a6-462d-a7ec-4cd6636512d0	2022-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LISINOPRIL generic name: LISINOPRIL

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 36 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-2072	Lisinopril	lisinopril	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2073	Lisinopril	lisinopril	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2074	Lisinopril	lisinopril	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2075	Lisinopril	lisinopril	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2076	Lisinopril	lisinopril	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2077	Lisinopril	lisinopril	Mylan Pharmaceuticals Inc.	ANDA	Current
43353-071	Lisinopril	lisinopril	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-121	Lisinopril	lisinopril	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-168	Lisinopril	lisinopril	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-169	Lisinopril	lisinopril	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-179	Lisinopril	lisinopril	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
50090-3388	Lisinopril	lisinopril	A-S Medication Solutions	ANDA	Current
51079-981	Lisinopril	lisinopril	Mylan Institutional Inc.	ANDA	Current
51079-982	Lisinopril	lisinopril	Mylan Institutional Inc.	ANDA	Current
51079-983	Lisinopril	lisinopril	Mylan Institutional Inc.	ANDA	Current
53808-0104	Lisinopril	lisinopril	State of Florida DOH Central Pharmacy	ANDA	Current
53808-0702	Lisinopril	lisinopril	State of Florida DOH Central Pharmacy	ANDA	Current
55154-5051	Lisinopril	lisinopril	Cardinal Health	ANDA	Current
55154-5051	Lisinopril	lisinopril	Cardinal Health	ANDA	Current
55154-5052	Lisinopril	lisinopril	Cardinal Health	ANDA	Current
55154-5052	Lisinopril	lisinopril	Cardinal Health	ANDA	Current
55154-5053	Lisinopril	lisinopril	Cardinal Health	ANDA	Current
55154-5053	Lisinopril	lisinopril	Cardinal Health	ANDA	Current
55154-5082	Lisinopril	lisinopril	Cardinal Health	ANDA	Current
55154-5082	Lisinopril	lisinopril	Cardinal Health	ANDA	Current
60429-206	Lisinopril	lisinopril	Golden State Medical Supply Inc.	ANDA	Current
60429-207	Lisinopril	lisinopril	Golden State Medical Supply Inc.	ANDA	Current
60429-208	Lisinopril	lisinopril	Golden State Medical Supply Inc.	ANDA	Current
60429-209	Lisinopril	lisinopril	Golden State Medical Supply Inc.	ANDA	Current
60429-211	Lisinopril	lisinopril	Golden State Medical Supply Inc.	ANDA	Current
60429-212	Lisinopril	lisinopril	Golden State Medical Supply Inc.	ANDA	Current
70518-0402	Lisinopril	lisinopril	REMEDYREPACK INC.	ANDA	Current
70518-0575	Lisinopril	lisinopril	REMEDYREPACK INC.	ANDA	Current
70518-0575	Lisinopril	lisinopril	REMEDYREPACK INC.	ANDA	Current
70518-0726	Lisinopril	lisinopril	REMEDYREPACK INC.	ANDA	Current
70518-0726	Lisinopril	lisinopril	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8861	ORIG	2004-06-24