Application 077606

Type: ANDA
Sponsor: AUROBINDO

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
A077606-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL	12.5MG;10MG	TABLET / ORAL	AB	2006-03-14
A077606-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL	12.5MG;20MG	TABLET / ORAL	AB	2006-03-14
A077606-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL	25MG;20MG	TABLET / ORAL	AB	2006-03-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077606-001	AB
A077606-002	AB
A077606-003	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	A077606-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2006-03-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077606-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2006-03-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077606-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2006-03-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077606-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2006-03-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077606-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2006-03-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077606-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2006-03-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077606-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2006-03-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077606-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2006-03-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077606-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2006-03-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077606-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2006-03-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077606-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2006-03-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077606-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2006-03-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077606-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2006-03-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077606-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2006-03-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077606-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2006-03-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077606-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2006-03-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077606-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2006-03-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077606-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2006-03-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077606-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2006-03-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077606-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2006-03-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077606-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2006-03-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077606-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2006-03-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077606-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2006-03-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077606-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2006-03-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077606-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2006-03-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077606-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2006-03-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077606-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2006-03-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077606-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2006-03-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077606-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2006-03-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077606-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2006-03-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077606-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2006-03-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077606-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2006-03-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077606-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2006-03-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077606-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2006-03-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077606-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2006-03-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077606-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2006-03-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077606-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2006-03-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077606-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2006-03-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077606-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2006-03-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077606-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2006-03-14	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077606-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077606-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077606-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077606-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077606-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077606-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077606-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077606-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077606-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077606-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077606-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077606-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077606-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077606-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077606-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077606-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077606-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077606-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077606-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077606-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077606-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077606-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077606-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077606-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077606-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077606-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077606-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077606-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077606-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077606-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077606-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077606-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077606-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077606-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077606-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077606-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077606-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077606-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077606-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077606-002	AB	1	`3f01610625f2…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE	Aurobindo Pharma Limited	d7214539-6c3d-466a-a474-6fde096fa182	2026-07-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077606 application number: ANDA077606 ndc (product): 65862-044 ndc (product): 65862-043 ndc (product): 65862-045

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 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16571-791	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	Rising Pharma Holdings, Inc.	ANDA	Current
16571-792	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	Rising Pharma Holdings, Inc.	ANDA	Current
16571-793	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	Rising Pharma Holdings, Inc.	ANDA	Current
57237-242	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	Citron Pharma LLC	ANDA	Current
57237-243	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	Citron Pharma LLC	ANDA	Current
57237-244	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	Citron Pharma LLC	ANDA	Current
65862-043	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-043	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-043	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-043	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-043	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-043	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-044	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-044	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-044	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-044	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-044	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-044	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-045	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-045	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-045	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-045	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-045	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-045	Lisinopril and Hydrochlorothiazide	Lisinopril and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current