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 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
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 · 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	A076230-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2002-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076230-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2002-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076230-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2002-07-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076230-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2002-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076230-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2002-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076230-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2002-07-01	`caaa826d4ba7…`
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…`

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	A076230-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076230-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076230-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076230-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076230-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076230-003	AB	1	`caaa826d4ba7…`
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…`

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 2 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	Bryant Ranch Prepack	b7d6f322-6415-4952-a2d4-7f46aca8af9d	2023-06-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076230 application number: ANDA076230
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS	Proficient Rx LP	84dba61d-cae2-4f21-9a9e-3088f356f838	2023-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076230 application number: ANDA076230

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 · 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