Application 076820

Type: ANDA
Sponsor: AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE	TABLET;ORAL	5MG	No	No
002	BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE	TABLET;ORAL	10MG	No	No
003	BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE	TABLET;ORAL	20MG	No	No
004	BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE	TABLET;ORAL	40MG	No	No

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

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
A076820-001	BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-02-03
A076820-002	BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2006-02-03
A076820-003	BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2006-02-03
A076820-004	BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2006-02-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076820-001	AB
A076820-002	AB
A076820-003	AB
A076820-004	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 1 of 5 · 172 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	A076820-001	BENAZEPRIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-02-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076820-002	BENAZEPRIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2006-02-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076820-003	BENAZEPRIL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2006-02-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076820-004	BENAZEPRIL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2006-02-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076820-001	BENAZEPRIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-02-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076820-002	BENAZEPRIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2006-02-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076820-003	BENAZEPRIL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2006-02-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076820-004	BENAZEPRIL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2006-02-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076820-001	BENAZEPRIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-02-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076820-002	BENAZEPRIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2006-02-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076820-003	BENAZEPRIL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2006-02-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076820-004	BENAZEPRIL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2006-02-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076820-001	BENAZEPRIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-02-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076820-002	BENAZEPRIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2006-02-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076820-003	BENAZEPRIL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2006-02-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076820-004	BENAZEPRIL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2006-02-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076820-001	BENAZEPRIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-02-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076820-002	BENAZEPRIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2006-02-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076820-003	BENAZEPRIL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2006-02-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076820-004	BENAZEPRIL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2006-02-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076820-001	BENAZEPRIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-02-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076820-002	BENAZEPRIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2006-02-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076820-003	BENAZEPRIL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2006-02-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076820-004	BENAZEPRIL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2006-02-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076820-001	BENAZEPRIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-02-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076820-002	BENAZEPRIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2006-02-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076820-003	BENAZEPRIL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2006-02-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076820-004	BENAZEPRIL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2006-02-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076820-001	BENAZEPRIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-02-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076820-002	BENAZEPRIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2006-02-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076820-003	BENAZEPRIL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2006-02-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076820-004	BENAZEPRIL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2006-02-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076820-001	BENAZEPRIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-02-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076820-002	BENAZEPRIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2006-02-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076820-003	BENAZEPRIL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2006-02-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076820-004	BENAZEPRIL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2006-02-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076820-001	BENAZEPRIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-02-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076820-002	BENAZEPRIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2006-02-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076820-003	BENAZEPRIL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2006-02-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076820-004	BENAZEPRIL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2006-02-03	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 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	A076820-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076820-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076820-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076820-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076820-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076820-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076820-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076820-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076820-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076820-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076820-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076820-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076820-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076820-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076820-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076820-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076820-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076820-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076820-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076820-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076820-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076820-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076820-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076820-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076820-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076820-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076820-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076820-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076820-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076820-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076820-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076820-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076820-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076820-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076820-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076820-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076820-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076820-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076820-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076820-004	AB	1	`5bbf6a4d5a75…`

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Benazepril Hydrochloride	BENAZEPRIL HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	e0ddcfbc-c9d8-45b1-9c11-0d1eff8c1e9e	2026-08-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076820 application number: ANDA076820
Benazepril Hydrochloride	BENAZEPRIL HYDROCHLORIDE	Cardinal Health 107, LLC	f265e6dd-f47e-4511-9468-282184bcd1b1	2026-04-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076820 application number: ANDA076820
Benazepril Hydrochloride	BENAZEPRIL HYDROCHLORIDE	Northwind Health Company, LLC	f99d3d0d-cee8-b260-e053-6294a90ac3cb	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076820 application number: ANDA076820
Benazepril Hydrochloride	BENAZEPRIL HYDROCHLORIDE	AvPAK	f004d7e2-fc45-8a37-e548-eeaaa327f9b5	2025-09-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076820 application number: ANDA076820
Benazepril Hydrochloride	BENAZEPRIL HYDROCHLORIDE	Bryant Ranch Prepack	cd1a7c8f-cc61-4ee4-a259-0b3329cced3e	2023-11-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076820 application number: ANDA076820 ndc (product): 71335-0854
Benazepril Hydrochloride	BENAZEPRIL HYDROCHLORIDE	Bryant Ranch Prepack	2b02c240-4393-48ed-a385-561ced7b7abf	2023-05-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076820 application number: ANDA076820 ndc (product): 71335-1086
Benazepril Hydrochloride	BENAZEPRIL HYDROCHLORIDE	Bryant Ranch Prepack	449e89a3-7bef-44eb-8d73-c77ece611cce	2023-05-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076820 application number: ANDA076820
Benazepril Hydrochloride	BENAZEPRIL HYDROCHLORIDE	Proficient Rx LP	9593989f-3129-48ad-9b30-f0b52fb3e91e	2019-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076820 application number: ANDA076820 ndc (product): 71205-244
Benazepril Hydrochloride	BENAZEPRIL HYDROCHLORIDE	Amneal Pharmaceuticals LLC	a216253b-27cb-42ef-b5a8-67fb05aafb88	2019-02-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076820 application number: ANDA076820

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 2 of 2 · 102 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70518-0216	Benazepril Hydrochloride	Benazepril Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3528	Benazepril Hydrochloride	Benazepril Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70934-228	Benazepril Hydrochloride	Benazepril Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-228	Benazepril Hydrochloride	Benazepril Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-228	Benazepril Hydrochloride	Benazepril Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-481	Benazepril Hydrochloride	Benazepril Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-481	Benazepril Hydrochloride	Benazepril Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-545	Benazepril Hydrochloride	Benazepril Hydrochloride	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
71205-244	Benazepril Hydrochloride	Benazepril Hydrochloride	Proficient Rx LP	ANDA	Current
71205-244	Benazepril Hydrochloride	Benazepril Hydrochloride	Proficient Rx LP	ANDA	Current
71335-0854	Benazepril Hydrochloride	Benazepril Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0854	Benazepril Hydrochloride	Benazepril Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0854	Benazepril Hydrochloride	Benazepril Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0854	Benazepril Hydrochloride	Benazepril Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0854	Benazepril Hydrochloride	Benazepril Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0854	Benazepril Hydrochloride	Benazepril Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1086	Benazepril Hydrochloride	Benazepril Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1086	Benazepril Hydrochloride	Benazepril Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1086	Benazepril Hydrochloride	Benazepril Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1299	Benazepril Hydrochloride	Benazepril Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1299	Benazepril Hydrochloride	Benazepril Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1299	Benazepril Hydrochloride	Benazepril Hydrochloride	Bryant Ranch Prepack	ANDA	Current