Application 077912

Type: ANDA
Sponsor: LUPIN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL	TABLET;ORAL	12.5MG;10MG	No	No
002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL	TABLET;ORAL	12.5MG;20MG	No	No
003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL	TABLET;ORAL	25MG;20MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A077912-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL	12.5MG;10MG	TABLET / ORAL	AB	2006-09-27
A077912-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL	12.5MG;20MG	TABLET / ORAL	AB	2006-09-27
A077912-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL	25MG;20MG	TABLET / ORAL	AB	2006-09-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A077912-001	AB
A077912-002	AB
A077912-003	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 4 · 129 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	A077912-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2006-09-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077912-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2006-09-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077912-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2006-09-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077912-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2006-09-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077912-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2006-09-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077912-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2006-09-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077912-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2006-09-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077912-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2006-09-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077912-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2006-09-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077912-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2006-09-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077912-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2006-09-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077912-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2006-09-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077912-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2006-09-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077912-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2006-09-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077912-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2006-09-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077912-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2006-09-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077912-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2006-09-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077912-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2006-09-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077912-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2006-09-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077912-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2006-09-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077912-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2006-09-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077912-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2006-09-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077912-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2006-09-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077912-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2006-09-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077912-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2006-09-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077912-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2006-09-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077912-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2006-09-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077912-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2006-09-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077912-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2006-09-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077912-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2006-09-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077912-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2006-09-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077912-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2006-09-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077912-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2006-09-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077912-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2006-09-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077912-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2006-09-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077912-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2006-09-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077912-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2006-09-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077912-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2006-09-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077912-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2006-09-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077912-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2006-09-27	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 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	A077912-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077912-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077912-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077912-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077912-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077912-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077912-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077912-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077912-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077912-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077912-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077912-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077912-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077912-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077912-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077912-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077912-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077912-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077912-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077912-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077912-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077912-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077912-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077912-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077912-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077912-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077912-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077912-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077912-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077912-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077912-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077912-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077912-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077912-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077912-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077912-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077912-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077912-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077912-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077912-001	AB	1	`301d65b070ca…`

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 2 · 27 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE	REMEDYREPACK INC.	3857ac53-0435-4d68-8066-c22291414889	2026-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077912 application number: ANDA077912 ndc (product): 70518-0382
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE	REMEDYREPACK INC.	868b1442-c412-4ee8-9798-f2408cd2249a	2026-06-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077912 application number: ANDA077912 ndc (product): 70518-0196
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE	REMEDYREPACK INC.	408e797a-2cf3-4ee6-9f9b-179a8cf3d799	2026-06-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077912 application number: ANDA077912 ndc (product): 70518-0174
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE	Coupler LLC	52b90789-2902-3ab9-e063-6394a90a5abb	2026-05-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077912 application number: ANDA077912
LISINOPRIL AND HYDROCHLOROTHIAZIDE	LISINOPRIL AND HYDROCHLOROTHIAZIDE	Preferred Pharmaceuticals, Inc.	5aa18b0b-4688-493a-a5ae-cb056ea6c0e3	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077912 application number: ANDA077912 ndc (product): 68788-9807 ndc (product): 68788-9809 ndc (product): 68788-9808
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	544b75eb-55f1-4164-9b83-39f6bc5fb479	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077912 application number: ANDA077912 ndc (product): 71335-0479
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	019ac336-0dc3-ec89-3e0a-09110e0fc30b	2026-04-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077912 application number: ANDA077912
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	eac8c44f-cf77-6a30-cfd7-7cffffc79bd6	2026-04-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077912 application number: ANDA077912
LISINOPRIL AND HYDROCHLOROTHIAZIDE	LISINOPRIL AND HYDROCHLOROTHIAZIDE	St Marys Medical Park Pharmacy	e7b68ea6-4fc8-441a-9640-1ccd3a482d8e	2026-03-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077912 application number: ANDA077912
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE	Legacy Pharmaceutical Packaging, LLC	6d729ec5-7311-4534-9999-9d6fa4f3ba2f	2026-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077912 application number: ANDA077912 ndc (product): 68645-558
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE	PD-Rx Pharmaceuticals, Inc.	8808879d-8c7e-45d1-8a49-c05d2cf845d3	2026-01-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077912 application number: ANDA077912
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE	PD-Rx Pharmaceuticals, Inc.	00f67e1a-6999-4295-9c9f-fcb1ce9711b8	2026-01-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077912 application number: ANDA077912
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE	PD-Rx Pharmaceuticals, Inc.	ec23c75d-68d5-46d0-be56-b96ddba19ed6	2026-01-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077912 application number: ANDA077912
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE	Northwind Health Company, LLC	f2b94985-c79d-40e3-e053-2a95a90a0d78	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077912 application number: ANDA077912
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE	Northwind Health Company, LLC	c97e38f2-7163-4d4e-a694-4d0612423e53	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077912 application number: ANDA077912
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE	Northwind Health Company, LLC	3984e6b9-2d88-47f0-af09-cce428bba14f	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077912 application number: ANDA077912
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE	QPharma, Inc.	c80b2164-3795-6668-e053-2a95a90a4d45	2025-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077912 application number: ANDA077912
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE	Lupin Pharmaceuticals, Inc.	515f735c-5dba-43d9-8a58-97a319cafd56	2025-11-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077912 application number: ANDA077912
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	cd62e287-b648-459a-9414-621686c6b607	2025-11-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077912 application number: ANDA077912
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	316e9226-e63e-466d-8143-f1edc7288fca	2025-11-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077912 application number: ANDA077912

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 3 of 3 · 221 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68645-558	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68645-558	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68645-558	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68645-588	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68645-588	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68788-9807	LISINOPRIL AND HYDROCHLOROTHIAZIDE	LISINOPRIL AND HYDROCHLOROTHIAZIDE	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9807	LISINOPRIL AND HYDROCHLOROTHIAZIDE	LISINOPRIL AND HYDROCHLOROTHIAZIDE	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9807	LISINOPRIL AND HYDROCHLOROTHIAZIDE	LISINOPRIL AND HYDROCHLOROTHIAZIDE	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9807	LISINOPRIL AND HYDROCHLOROTHIAZIDE	LISINOPRIL AND HYDROCHLOROTHIAZIDE	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9807	LISINOPRIL AND HYDROCHLOROTHIAZIDE	LISINOPRIL AND HYDROCHLOROTHIAZIDE	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9808	LISINOPRIL AND HYDROCHLOROTHIAZIDE	LISINOPRIL AND HYDROCHLOROTHIAZIDE	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9808	LISINOPRIL AND HYDROCHLOROTHIAZIDE	LISINOPRIL AND HYDROCHLOROTHIAZIDE	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9808	LISINOPRIL AND HYDROCHLOROTHIAZIDE	LISINOPRIL AND HYDROCHLOROTHIAZIDE	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9808	LISINOPRIL AND HYDROCHLOROTHIAZIDE	LISINOPRIL AND HYDROCHLOROTHIAZIDE	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9808	LISINOPRIL AND HYDROCHLOROTHIAZIDE	LISINOPRIL AND HYDROCHLOROTHIAZIDE	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9809	LISINOPRIL AND HYDROCHLOROTHIAZIDE	LISINOPRIL AND HYDROCHLOROTHIAZIDE	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9809	LISINOPRIL AND HYDROCHLOROTHIAZIDE	LISINOPRIL AND HYDROCHLOROTHIAZIDE	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9809	LISINOPRIL AND HYDROCHLOROTHIAZIDE	LISINOPRIL AND HYDROCHLOROTHIAZIDE	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9809	LISINOPRIL AND HYDROCHLOROTHIAZIDE	LISINOPRIL AND HYDROCHLOROTHIAZIDE	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9809	LISINOPRIL AND HYDROCHLOROTHIAZIDE	LISINOPRIL AND HYDROCHLOROTHIAZIDE	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-0174	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-0174	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-0174	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-0174	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-0174	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-0174	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-0174	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-0174	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-0174	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-0174	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-0196	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-0196	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-0196	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-0196	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-0196	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-0196	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-0196	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-0196	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-0382	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-0382	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-0382	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-0382	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-0382	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-0382	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-0382	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70934-128	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-128	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-128	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-128	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-718	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
70934-718	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
70934-888	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71205-022	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	Proficient Rx LP	ANDA	Current
71205-022	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	Proficient Rx LP	ANDA	Current
71205-022	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	Proficient Rx LP	ANDA	Current
71205-022	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	Proficient Rx LP	ANDA	Current
71335-0479	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	Bryant Ranch Prepack	ANDA	Current
71335-0479	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	Bryant Ranch Prepack	ANDA	Current
71335-0479	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	Bryant Ranch Prepack	ANDA	Current
71610-375	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-375	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
43990	ORIG	2009-05-30
44629	ORIG	2006-10-10