Application 076230

Type: ANDA
Sponsor: PRINSTON INC

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 1.

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
A076230-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL	12.5MG;10MG	TABLET / ORAL	AB	2002-07-01
A076230-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL	12.5MG;20MG	TABLET / ORAL	AB	2002-07-01
A076230-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL	25MG;20MG	TABLET / ORAL	AB	2002-07-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076230-001	AB
A076230-002	AB
A076230-003	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 · 123 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
2026-02-19 14:30 UTC	2026-02	A076230-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076230-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076230-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2002-07-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076230-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2002-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076230-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2002-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076230-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2002-07-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076230-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076230-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076230-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2002-07-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076230-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2002-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076230-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2002-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076230-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2002-07-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076230-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2002-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076230-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2002-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076230-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2002-07-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076230-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2002-07-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076230-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2002-07-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076230-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2002-07-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076230-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2002-07-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076230-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2002-07-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076230-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2002-07-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076230-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2002-07-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076230-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2002-07-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076230-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2002-07-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076230-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2002-07-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076230-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2002-07-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076230-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2002-07-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076230-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2002-07-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076230-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2002-07-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076230-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2002-07-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076230-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2002-07-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076230-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2002-07-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076230-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2002-07-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076230-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2002-07-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076230-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2002-07-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076230-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2002-07-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076230-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2002-07-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076230-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2002-07-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076230-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2002-07-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076230-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2002-07-01	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076230-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076230-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076230-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076230-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076230-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076230-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076230-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076230-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076230-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076230-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076230-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076230-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076230-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076230-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076230-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076230-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076230-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076230-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076230-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076230-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076230-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076230-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076230-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076230-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076230-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076230-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076230-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076230-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076230-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076230-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076230-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076230-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076230-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076230-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076230-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076230-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076230-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076230-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076230-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076230-001	AB	1	`8072bd15b7f6…`

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 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS	St. Mary's Medical Park Pharmacy	e1aa9682-b1ad-4a22-e053-2a95a90a0e2f	2026-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076230 application number: ANDA076230 ndc (product): 60760-519
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS	St. Mary's Medical Park Pharmacy	00b266d9-ac4a-e931-e063-6294a90a6a0b	2026-06-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076230 application number: ANDA076230
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS	Preferred Pharmaceuticals Inc.	5956a107-0f7b-49e7-b9c9-36790349b06e	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076230 application number: ANDA076230 ndc (product): 68788-8241
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS	Preferred Pharmaceuticals Inc.	9207c3bc-e12e-4017-8b85-0f928e744f64	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076230 application number: ANDA076230 ndc (product): 68788-8224
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS	Preferred Pharmaceuticals Inc.	fc4d7d0e-78a6-4d7e-ba53-aeeb008aa2dc	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076230 application number: ANDA076230
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS	REMEDYREPACK INC.	d383e0e5-4e00-44cc-9d6f-86e76f4e79e3	2026-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076230 application number: ANDA076230
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS	REMEDYREPACK INC.	3bea11a3-eb07-46b2-9b91-f8a48a2f3b7e	2026-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076230 application number: ANDA076230 ndc (product): 70518-3505
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS	A-S Medication Solutions	7d4ee5ec-5b68-453b-8d6e-214457a58159	2026-02-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076230 application number: ANDA076230
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS	A-S Medication Solutions	62e8c093-cd8e-4342-aadb-209c7e6699c8	2026-02-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076230 application number: ANDA076230 ndc (product): 50090-6204
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS	A-S Medication Solutions	c2396dd4-faf2-447c-bda5-2362dbbbe352	2026-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076230 application number: ANDA076230
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS	A-S Medication Solutions	22036b58-c1fe-45b5-ae08-93fdaf716528	2026-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076230 application number: ANDA076230 ndc (product): 50090-6034
Lisinopril/HCTZ	LISINOPRIL/HCTZ	Direct_Rx	4510c108-2683-f505-e063-6394a90ab0a4	2025-12-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076230 application number: ANDA076230
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS	Solco Healthcare LLC	96922ddc-e87f-4670-b22e-0ffd0d8f66e1	2025-07-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076230 application number: ANDA076230 ndc (product): 43547-421 ndc (product): 43547-420 ndc (product): 43547-422
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE	Advanced Rx Pharmacy of Tennessee, LLC	ecac0280-6faa-e7f3-e053-2995a90a2bd9	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076230 application number: ANDA076230 ndc (product): 80425-0207
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS	Aphena Pharma Solutions - Tennessee, LLC	2902430c-0bfe-483e-e063-6294a90a92d7	2024-12-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076230 application number: ANDA076230
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS	Bryant Ranch Prepack	cafb049d-724f-4daa-b210-4be2cc1e4e69	2024-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076230 application number: ANDA076230 ndc (product): 71335-2102
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS	NuCare Pharmaceuticals,Inc.	e0511312-0b07-be89-e053-2995a90ab1e5	2024-01-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076230 application number: ANDA076230 ndc (product): 68071-2740
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS	A-S Medication Solutions	3372e46d-8f18-44fd-a9c8-3d8a45d9acdc	2023-12-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076230 application number: ANDA076230 ndc (product): 50090-6062
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS	A-S Medication Solutions	ed019adb-0a18-4aba-9b09-a0c966322d96	2023-12-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076230 application number: ANDA076230
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS	Bryant Ranch Prepack	5885b1ff-715c-4f90-b43d-bddf94d61acd	2023-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076230 application number: ANDA076230 ndc (product): 71335-2091

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 26 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43547-420	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide Tablets	Solco Healthcare LLC	ANDA	Current
43547-420	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide Tablets	Solco Healthcare LLC	ANDA	Current
43547-421	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide Tablets	Solco Healthcare LLC	ANDA	Current
43547-421	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide Tablets	Solco Healthcare LLC	ANDA	Current
43547-422	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide Tablets	Solco Healthcare LLC	ANDA	Current
43547-422	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide Tablets	Solco Healthcare LLC	ANDA	Current
50090-6034	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide Tablets	A-S Medication Solutions	ANDA	Current
50090-6062	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide Tablets	A-S Medication Solutions	ANDA	Current
50090-6204	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide Tablets	A-S Medication Solutions	ANDA	Current
55700-979	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide Tablets	Quality Care Products, LLC	ANDA	Current
55700-979	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide Tablets	Quality Care Products, LLC	ANDA	Current
60760-519	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide Tablets	St Mary's Medical Park Pharmacy	ANDA	Current
68071-2691	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide Tablets	NuCare Pharmaceutocals,Inc.	ANDA	Current
68071-2691	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide Tablets	NuCare Pharmaceutocals,Inc.	ANDA	Current
68071-2740	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide Tablets	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2740	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide Tablets	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2823	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide Tablets	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2823	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide Tablets	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-8224	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide Tablets	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-8241	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide Tablets	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-3505	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide Tablets	REMEDYREPACK INC.	ANDA	Current
70518-3505	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide Tablets	REMEDYREPACK INC.	ANDA	Current
70518-3505	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide Tablets	REMEDYREPACK INC.	ANDA	Current
71335-2091	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide Tablets	Bryant Ranch Prepack	ANDA	Current
71335-2102	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide Tablets	Bryant Ranch Prepack	ANDA	Current
80425-0207	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current