Application 076059

Type: ANDA
Sponsor: WATSON LABS

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
A076059-001	LISINOPRIL	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01
A076059-002	LISINOPRIL	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01
A076059-003	LISINOPRIL	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01
A076059-004	LISINOPRIL	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01
A076059-005	LISINOPRIL	LISINOPRIL	30MG	TABLET / ORAL	AB	2002-07-01
A076059-006	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
A076059-001	AB
A076059-002	AB
A076059-003	AB
A076059-004	AB
A076059-005	AB
A076059-006	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	A076059-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076059-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076059-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076059-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076059-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2002-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076059-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2002-07-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076059-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076059-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076059-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076059-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076059-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076059-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2002-07-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076059-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076059-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076059-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076059-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076059-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2002-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076059-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2002-07-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076059-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076059-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076059-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076059-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076059-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076059-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2002-07-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076059-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076059-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076059-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076059-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076059-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2002-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076059-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2002-07-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076059-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076059-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076059-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076059-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076059-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2002-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076059-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2002-07-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076059-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076059-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076059-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076059-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01	`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	A076059-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076059-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076059-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076059-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076059-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076059-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076059-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076059-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076059-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076059-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076059-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076059-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076059-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076059-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076059-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076059-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076059-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076059-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076059-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076059-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076059-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076059-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076059-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076059-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076059-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076059-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076059-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076059-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076059-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076059-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076059-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076059-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076059-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076059-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076059-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076059-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076059-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076059-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076059-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076059-004	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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lisinopril	LISINOPRIL	QPharma Inc	b17cd16b-8d0a-4cfa-bd48-2529983fcd12	2025-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076059 application number: ANDA076059
Lisinopril	LISINOPRIL	NuCare Pharmaceuticals,Inc.	964c7f28-f62e-30b5-e053-2a95a90ab84c	2025-01-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076059 application number: ANDA076059 ndc (product): 68071-5098
Lisinopril	LISINOPRIL	Bryant Ranch Prepack	33ebf3f2-cd71-4d8b-ac22-1a20a068a13d	2024-10-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076059 application number: ANDA076059 ndc (product): 71335-1380
Lisinopril	LISINOPRIL	NuCare Pharmaceuticals,Inc.	ab9bc1b4-60cc-76ea-e053-2995a90ac203	2024-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076059 application number: ANDA076059 ndc (product): 68071-2224
Lisinopril	LISINOPRIL	NuCare Pharmaceuticals,Inc.	90a589a9-acc2-bfbe-e053-2995a90a0bd2	2024-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076059 application number: ANDA076059 ndc (product): 68071-5036
Lisinopril	LISINOPRIL	NuCare Pharmaceuticals,Inc.	95376981-4620-c9aa-e053-2995a90a1390	2024-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076059 application number: ANDA076059 ndc (product): 68071-5089
Lisinopril	LISINOPRIL	Bryant Ranch Prepack	3783ab4c-2bed-414e-8927-62d47e3e3496	2024-01-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076059 application number: ANDA076059
Lisinopril	LISINOPRIL	Bryant Ranch Prepack	5af2444f-438c-4ea6-96e8-3dba1af9e1a5	2024-01-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076059 application number: ANDA076059
Lisinopril	LISINOPRIL	Proficient Rx LP	8a14eaa6-cb8b-4088-ba15-840b587ab1f7	2022-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076059 application number: ANDA076059
Lisinopril	LISINOPRIL	Proficient Rx LP	55a57d80-6bed-44a3-b3ea-6bb44c34cbfc	2021-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076059 application number: ANDA076059 ndc (product): 71205-626
Lisinopril	LISINOPRIL	Actavis Pharma, Inc.	43e2c8d1-3704-4323-bcaf-f582572b81f7	2017-11-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076059 application number: ANDA076059

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 123 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
67296-1154	Lisinopril	Lisinopril	RedPharm Drug, Inc.	ANDA	Current
68071-1843	Lisinopril	Lisinopril	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-1843	Lisinopril	Lisinopril	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2224	Lisinopril	Lisinopril	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2224	Lisinopril	Lisinopril	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4871	Lisinopril	Lisinopril	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4871	Lisinopril	Lisinopril	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4931	Lisinopril	Lisinopril	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4931	Lisinopril	Lisinopril	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5036	Lisinopril	Lisinopril	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5036	Lisinopril	Lisinopril	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5077	Lisinopril	Lisinopril	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5077	Lisinopril	Lisinopril	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5089	Lisinopril	Lisinopril	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5089	Lisinopril	Lisinopril	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5090	Lisinopril	Lisinopril	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5090	Lisinopril	Lisinopril	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5098	Lisinopril	Lisinopril	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5098	Lisinopril	Lisinopril	NuCare Pharmaceuticals,Inc.	ANDA	Current
68645-272	Lisinopril	Lisinopril	Legacy Pharmaceutical Packaging	ANDA	Current
68788-7633	Lisinopril	Lisinopril	Preferred Pharmaceuticlals Inc.	ANDA	Current
68788-7633	Lisinopril	Lisinopril	Preferred Pharmaceuticlals Inc.	ANDA	Current
68788-7633	Lisinopril	Lisinopril	Preferred Pharmaceuticlals Inc.	ANDA	Current
68788-7831	Lisinopril	Lisinopril	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7831	Lisinopril	Lisinopril	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7966	Lisinopril	Lisinopril	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7966	Lisinopril	Lisinopril	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-0393	Lisinopril	Lisinopril	REMEDYREPACK INC.	ANDA	Current
70518-0661	Lisinopril	Lisinopril	REMEDYREPACK INC.	ANDA	Current
70518-1117	Lisinopril	Lisinopril	REMEDYREPACK INC.	ANDA	Current
70518-1117	Lisinopril	Lisinopril	REMEDYREPACK INC.	ANDA	Current
70518-1660	Lisinopril	Lisinopril	REMEDYREPACK INC.	ANDA	Current
70518-1665	Lisinopril	Lisinopril	REMEDYREPACK INC.	ANDA	Current
70518-1665	Lisinopril	Lisinopril	REMEDYREPACK INC.	ANDA	Current
70518-1665	Lisinopril	Lisinopril	REMEDYREPACK INC.	ANDA	Current
70934-200	Lisinopril	Lisinopril	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-200	Lisinopril	Lisinopril	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-261	Lisinopril	Lisinopril	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-261	Lisinopril	Lisinopril	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-261	Lisinopril	Lisinopril	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-633	Lisinopril	Lisinopril	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
71205-626	Lisinopril	Lisinopril	Proficient Rx LP	ANDA	Current
71335-1380	Lisinopril	Lisinopril	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8858	ORIG	2003-04-10