Application 076342

Type: ANDA
Sponsor: ANI PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE	TABLET;ORAL	5MG;6.25MG	No	No
002	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE	TABLET;ORAL	10MG;12.5MG	No	No
003	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE	TABLET;ORAL	20MG;12.5MG	No	No
004	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE	TABLET;ORAL	20MG;25MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A076342-001	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB	2004-02-11
A076342-002	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB	2004-02-11
A076342-003	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	2004-02-11
A076342-004	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE	20MG;25MG	TABLET / ORAL	AB	2004-02-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A076342-001	AB
A076342-002	AB
A076342-003	AB
A076342-004	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 2 of 5 · 176 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
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076342-001	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB	2004-02-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076342-002	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB	2004-02-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076342-003	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	2004-02-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076342-004	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	20MG;25MG	TABLET / ORAL	AB	2004-02-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076342-001	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB	2004-02-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076342-002	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB	2004-02-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076342-003	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	2004-02-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076342-004	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	20MG;25MG	TABLET / ORAL	AB	2004-02-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076342-001	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB	2004-02-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076342-002	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB	2004-02-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076342-003	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	2004-02-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076342-004	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	20MG;25MG	TABLET / ORAL	AB	2004-02-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076342-001	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB	2004-02-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076342-002	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB	2004-02-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076342-003	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	2004-02-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076342-004	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	20MG;25MG	TABLET / ORAL	AB	2004-02-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076342-001	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB	2004-02-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076342-002	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB	2004-02-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076342-003	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	2004-02-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076342-004	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	20MG;25MG	TABLET / ORAL	AB	2004-02-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076342-001	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB	2004-02-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076342-002	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB	2004-02-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076342-003	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	2004-02-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076342-004	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	20MG;25MG	TABLET / ORAL	AB	2004-02-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076342-001	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL	AB	2004-02-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076342-002	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB	2004-02-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076342-003	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	2004-02-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076342-004	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	20MG;25MG	TABLET / ORAL	AB	2004-02-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076342-001	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL		2004-02-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076342-002	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL		2004-02-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076342-003	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL		2004-02-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076342-004	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	20MG;25MG	TABLET / ORAL		2004-02-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076342-001	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL		2004-02-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076342-002	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL		2004-02-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076342-003	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL		2004-02-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076342-004	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	20MG;25MG	TABLET / ORAL		2004-02-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076342-001	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET / ORAL		2004-02-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076342-002	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL		2004-02-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076342-003	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL		2004-02-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076342-004	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	20MG;25MG	TABLET / ORAL		2004-02-11	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 112 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A076342-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A076342-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A076342-003	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A076342-004	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A076342-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076342-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076342-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076342-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076342-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076342-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076342-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076342-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076342-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076342-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076342-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076342-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076342-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076342-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076342-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076342-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076342-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076342-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076342-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076342-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076342-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076342-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076342-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076342-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076342-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076342-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076342-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076342-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076342-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076342-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076342-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076342-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076342-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076342-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076342-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076342-004	AB	1	`2680178bc6a6…`

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
Benazepril Hydrochloride and Hydrochlorothiazide	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	ANI Pharmaceuticals, Inc.	e6527adf-8c74-4d81-9199-d56a7fca895e	2025-11-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076342 application number: ANDA076342 ndc (product): 62559-416 ndc (product): 62559-417 ndc (product): 62559-414 ndc (product): 62559-415

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
62559-414	Benazepril Hydrochloride and Hydrochlorothiazide	Benazepril Hydrochloride and Hydrochlorothiazide	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-415	Benazepril Hydrochloride and Hydrochlorothiazide	Benazepril Hydrochloride and Hydrochlorothiazide	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-416	Benazepril Hydrochloride and Hydrochlorothiazide	Benazepril Hydrochloride and Hydrochlorothiazide	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-417	Benazepril Hydrochloride and Hydrochlorothiazide	Benazepril Hydrochloride and Hydrochlorothiazide	ANI Pharmaceuticals, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8895	ORIG	2004-02-12