Benazepril Hydrochloride

Product NDC: 68071-5088
Requested package NDC: 68071-5088-0
11-digit product format: 680715088
Labeler code: 68071
Product ID: 68071-5088_bbf27a35-62a1-1c29-e053-2a95a90a1f54
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Benazepril Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA076820
Marketing category: ANDA
Marketing start: 2010-02-02
Marketing end: 0000-00-00
Substance: BENAZEPRIL HYDROCHLORIDE
Active strength: 5 mg/1
Pharmacologic classes: Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68071-5088	68071-5088-0	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 168 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
2026-08-18 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…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076820-001	BENAZEPRIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-02-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076820-002	BENAZEPRIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2006-02-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076820-003	BENAZEPRIL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2006-02-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076820-004	BENAZEPRIL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2006-02-03	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076820-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076820-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076820-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076820-004	AB	1	`d8e5a09893c0…`

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2024-06-19	These highlights do not include all the information needed to use BENAZEPRIL HCl TABLETS safely and effectively. See full prescribing information for BENAZEPRIL HCl TABLETS. BENAZEPRIL HCl tablets, for oral use Initial U.S. Approval: 1991
2023-01-30	These highlights do not include all the information needed to use BENAZEPRIL HCl TABLETS safely and effectively. See full prescribing information for BENAZEPRIL HCl TABLETS. BENAZEPRIL HCl tablets, for oral use Initial U.S. Approval: 1991
2021-02-22	These highlights do not include all the information needed to use BENAZEPRIL HCl TABLETS safely and effectively. See full prescribing information for BENAZEPRIL HCl TABLETS. BENAZEPRIL HCl tablets, for oral use Initial U.S. Approval: 1991
2021-01-29	These highlights do not include all the information needed to use BENAZEPRIL HCl TABLETS safely and effectively. See full prescribing information for BENAZEPRIL HCl TABLETS. BENAZEPRIL HCl tablets, for oral use Initial U.S. Approval: 1991

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
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
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
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
N1SN99T69T	BENAZEPRIL HYDROCHLORIDE	86541-74-4	BENAZEPRIL HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-5088-0	68071508800	100 TABLET in 1 BOTTLE (68071-5088-0)	100 tablet	2019-10-18	0000-00-00	No	No	Current